本文選題：藥品缺陷 + 因果關(guān)系　； 參考：《內(nèi)蒙古大學(xué)》2015年碩士論文

【摘要】：藥品雖然具有一定的特殊性但仍屬于產(chǎn)品,藥品缺陷責(zé)任適用無過錯(cuò)責(zé)任原則,構(gòu)成要件有三：藥品存在缺陷；受害人遭受損害；缺陷與損害具有因果關(guān)系。本論文立足我國的法律規(guī)定,借鑒國外相關(guān)立法、學(xué)說及判例,對(duì)如何認(rèn)定和證明藥品缺陷、缺陷與損害之間的因果關(guān)系以及藥品缺陷責(zé)任承擔(dān)主體范圍進(jìn)行探討,以期對(duì)我國司法實(shí)踐中藥品缺陷責(zé)任認(rèn)定提出建設(shè)性意見。論文主要分四部分展開。第一部分關(guān)于藥品缺陷的界定。通過分析指明,藥品缺陷是指藥品具有的不合理危險(xiǎn)。藥品缺陷的本質(zhì)涉及藥品的安全性問題,由于藥品標(biāo)準(zhǔn)并非藥品的安全標(biāo)準(zhǔn),藥品符合標(biāo)準(zhǔn)并不能保證絕對(duì)安全,因此,合格藥品仍可構(gòu)成缺陷。第二部分關(guān)于藥品缺陷的認(rèn)定和證明。此部分探討三個(gè)問題。—是缺陷的認(rèn)定。藥品缺陷在具體認(rèn)定時(shí)應(yīng)對(duì)處方藥和非處方藥適用不同的認(rèn)定標(biāo)準(zhǔn),并應(yīng)區(qū)分設(shè)計(jì)、制造及警示缺陷適用不同的認(rèn)定標(biāo)準(zhǔn)。二是藥品不良反應(yīng)是否構(gòu)成缺陷的認(rèn)定。藥品不良反應(yīng)以合格藥品為基礎(chǔ),由于合格藥品也可能具有缺陷,因而藥品不良反應(yīng)是否構(gòu)成缺陷有探討的空間。重點(diǎn)探討藥品不良反應(yīng)在何種情形下可認(rèn)定為缺陷。在第三個(gè)問題中將詳述事實(shí)自證規(guī)則在缺陷證明中的作用。第三部分關(guān)于藥品缺陷責(zé)任構(gòu)成中的因果關(guān)系。藥品缺陷責(zé)任因果關(guān)系的證明采蓋然性因果關(guān)系規(guī)則,并輔助疫學(xué)因果關(guān)系理論。在蓋然性規(guī)則下,有時(shí)需運(yùn)用一些具體的方法,如市場(chǎng)份額理論和專家證人制度。此外,還將對(duì)最高院《關(guān)于審理食品藥品糾紛案件適用法律若干問題的規(guī)定》第5條對(duì)因果關(guān)系證明規(guī)則的規(guī)定予以分析。第四部分則關(guān)于藥品缺陷責(zé)任的承擔(dān)主體。在責(zé)任主體上,有意義的探討在于對(duì)生產(chǎn)者范圍的界定以及醫(yī)療機(jī)構(gòu)的責(zé)任承擔(dān)問題。關(guān)于藥品生產(chǎn)者范圍的界定,主張將藥品原材料的生產(chǎn)者、藥品的準(zhǔn)生產(chǎn)者認(rèn)定為藥品生產(chǎn)者,這對(duì)受害者賠償請(qǐng)求的實(shí)現(xiàn)具有現(xiàn)實(shí)意義。對(duì)于醫(yī)療機(jī)構(gòu)的責(zé)任承擔(dān)則重點(diǎn)探討醫(yī)療機(jī)構(gòu)在藥品缺陷責(zé)任承擔(dān)中的法律地位,也即《侵權(quán)責(zé)任法》第59條有無歸責(zé)基礎(chǔ)。
[Abstract]:Although the drug has certain particularity, it still belongs to the product. The principle of no-fault liability is applicable to the liability for drug defects. There are three constitutive requirements: the drug has defects, the victims suffer damage, and the defects and damages have causality. Based on the laws and regulations of our country, this paper discusses how to identify and prove the defects of drugs, the causality between defects and damages, and the scope of the main body of liability for drug defects, drawing on the relevant legislation, theories and precedents of foreign countries. In order to put forward constructive suggestions on the cognizance of drug defect liability in judicial practice in our country. The thesis is divided into four parts. The first part is about the definition of drug defect. Through the analysis, it is pointed out that drug defect refers to the unreasonable danger of drugs. The essence of drug defect is related to the safety of drugs. Because the drug standard is not the safety standard of drugs, the conformity of drugs with the standard can not guarantee the absolute safety, so qualified drugs can still constitute defects. The second part is about the identification and proof of drug defect. This section discusses three problems.-is the identification of defects. Different identification standards should be applied to prescription drugs and over-the-counter drugs, and different identification standards should be applied to design, manufacture and warning defects. The second is whether adverse drug reactions constitute defects. Adverse drug reactions (ADR) are based on qualified drugs. As qualified drugs may also have defects, there is room for discussion on whether adverse drug reactions constitute defects. Emphasis is placed on the circumstances under which adverse drug reactions can be identified as defects. In the third question, the role of the fact-proof rule in the defect proof will be discussed in detail. The third part deals with the causality in the composition of liability for drug defects. The proof of causality of drug defect liability adopts the rule of causality and adjusts the theory of epidemic causality. Under the rule of probability, some specific methods, such as market share theory and expert witness system, are sometimes used. In addition, the article 5 of the Supreme Court "on the provisions of applicable Law on the trial of Food and Drug disputes" will also analyze the provisions of the rules of proof of causality. The fourth part is about the main body of the liability for drug defects. On the subject of responsibility, the meaningful discussion lies in the definition of producer scope and the responsibility of medical institutions. As to the definition of the scope of drug producers, it is proposed that the producers of raw materials and quasi-producers of drugs should be regarded as drug producers, which is of practical significance to the realization of victims' claims for compensation. For the liability of medical institutions, the emphasis is to discuss the legal status of medical institutions in the responsibility of drug defects, that is, whether Article 59 of the Tort liability Law has the basis of imputation.
【學(xué)位授予單位】：內(nèi)蒙古大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2015
【分類號(hào)】：D922.294

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本文編號(hào)：1934981