本文選題：仿制藥 + 首仿藥��； 參考：《中南大學(xué)》2014年碩士論文

【摘要】：專利懸崖期的到來會(huì)對(duì)制藥行業(yè)產(chǎn)生深遠(yuǎn)的影響�！笆濉币詠�,我國(guó)大力發(fā)展仿制藥產(chǎn)業(yè),號(hào)召以專利到期高潮為契機(jī)改變我國(guó)仿制藥產(chǎn)業(yè)大而不精的現(xiàn)狀。而首仿藥作為首先成功仿制的藥品,直接關(guān)系到公眾享有可負(fù)擔(dān)醫(yī)療服務(wù)的時(shí)間,是最具代表性也最值得鼓勵(lì)的仿制藥。但目前我國(guó)首仿藥的法律法規(guī)體系并不完善,因此本選題極具研究意義。 相比之下,美國(guó)具備較完善的仿制藥法律法規(guī)體系,主要包括Hatch-Waxman法案、《藥品專利登記及ANDA停審期的管理規(guī)定》、仿制藥價(jià)格及效益計(jì)劃等仿制藥的專門性法律法規(guī)。本文在研習(xí)美國(guó)先進(jìn)制度的基礎(chǔ)上,結(jié)合我國(guó)目前仿制藥的法律法規(guī)現(xiàn)狀,總結(jié)出目前我國(guó)仿制藥法律法規(guī)體系中存在的問題：仿制藥法律地位不明確；仿制藥對(duì)照目錄制度缺失,導(dǎo)致藥品專利權(quán)信息和獨(dú)占權(quán)信息不透明；缺乏有效首仿藥激勵(lì)制度以及仿制藥使用制度不規(guī)范。針對(duì)上述問題,筆者在文章的最后提出了相應(yīng)的對(duì)策和建議,包括：確立仿制藥法律地位；建立仿制藥對(duì)照目錄制度；確立首仿藥激勵(lì)制度以及規(guī)范仿制藥使用制度。
[Abstract]:The arrival of the patent cliff will have a profound impact on the pharmaceutical industry. Since the 12th Five-Year Plan, China has made great efforts to develop the generic medicine industry and called on the climax of patent expiration to change the status quo of China's generic drug industry. As the first successful imitation drug, it is directly related to the public access to affordable medical services, is the most representative and most worthy of encouragement of generic drugs. However, the current legal system of the first imitation drug is not perfect, so this topic is of great significance. In contrast, the United States has a relatively complete system of laws and regulations on generic drugs, including the Hatch-Waxman Act, the regulations on the Administration of Drug Patent Registration and ANDA suspension, and the specific laws and regulations on generic drugs, such as the price and benefit plan of generic drugs. On the basis of studying American advanced system and combining with the current situation of laws and regulations of generic drugs in our country, this paper summarizes the existing problems in the legal system of generic drugs in our country: the legal status of generic drugs is not clear; The absence of the generic drug control catalogue system leads to the lack of transparency of patent information and exclusive right information, the lack of effective incentive system for imitating drugs and the non-standard system of generic drug use. At the end of the paper, the author puts forward the corresponding countermeasures and suggestions, including: establishing the legal status of generic drugs; establishing the control catalogue system of generic drugs; establishing the incentive system of the first imitation drugs and regulating the use of generic drugs.
【學(xué)位授予單位】：中南大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類號(hào)】：D922.16

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