製造或銷售偽禁藥物之民事侵權責任研究

Abstract

偽禁藥物長久以來為各國主管機關與法制人員頭痛的問題，其上下游生態系統包括從原物料生產、採購、配方設計、調製、製造生產、包裝、物流倉儲、藥商、供應商、醫療院所、藥局、網路平台、及末端使用藥品的患者和消費者。在各個供應環節都有可能有因偽禁藥物的製造、交易、供應、以及患者或消費者使用偽禁藥物後對生命或身體健康的影響，所產生不同型態的侵權損害。 由於偽禁藥物未經合格藥廠及當地法令審查核准製造或輸入，當有藥品不良反應產生時，消費者也因不符合藥濟法規定而無法申請救濟。如在非法管道購買到偽禁藥物，有時又因舉證困難，更難以法申訴。也有部分消費者認為是被「詐欺」了，誤信不實廣告導致權益受到損害（無論是財產或非財產上），對於在合法銷售通路上購買到偽禁藥物的民眾，卻因偽禁藥物為非法藥品，無法請求藥害救濟，如未能雙方合意和解，就必須以消費者保護法或民法提起訴訟來解決。 以往，主管機關針對非法輸入的偽禁藥物多以海關、邊境管理為主要監控管道，但現今網購已是許多商品的強勢通路，偽禁藥物的流竄不僅限於實體通路，甚而做到平台線上線下整合（不是Foodpanda，是Drugpanda），更助長了跨境偽禁藥物的猖獗。儘管衛生福利部食品藥物管理署持續在網路抽查偽禁藥物並教育消費者不要購買來源不明的藥物，但有需求就有供給，隨著此類交易行為的日益頻繁下，偽禁藥物犯罪之隱憂似成為難以根絕之問題。 民眾在合法或非法管道購買到偽禁藥物不僅花錢，對身體健康可能產生潛在危害、亦可能還有後續訴訟問題。非法之偽禁藥物，無論是藉由哪種交易模式，後續衍生出的管理成本，行政機關人力之負擔、國家稅收等，實為影響國家公益的問題。 故本文選定「製造或銷售偽禁藥物之民事侵權責任研究」議題來探討國內現有法規對民眾於通路不慎購買到偽禁藥物時，其相對應之損害賠償，並藉由目前的實務見解與法院判例，研討偽禁藥物在上下游供應鏈中供應商與通路合作廠商因偽禁藥物產生的相關侵權行為和損害賠償，以及對末端使用者民眾的影響。 本論文首先提出關於偽藥的問題意識，並以文獻探討及實務案例分析做為研究方法；第二章定義偽禁藥物與購買通路，以界定產生侵權損害的範圍；第三章討論偽禁藥物侵權之構成要件的認定，包含「故意過失及非故意過失」之加害行為，法律效果如「賠償範圍」、「懲罰性賠償」、「舉證責任」等；第四章以實務案例分析，以消保法第7條、第51條及民法第184條第2項、第194條、第195條之運用，以及「機會喪失」評論案例中民事賠償的觀點和爭議，並提出本文見解；最後第五章以結論與修法建議，認為現行法規對於偽禁藥物導致的民事責任與侵權法律效果，尚可從修法與行政管制方面加強。

Counterfeit and illegal drugs have long posed a significant challenge to regulatory authorities and legal professionals around the world. The ecosystem of counterfeit and illegal drugs spans the entire supply chain, including raw material production, procurement, formulation, preparation, production, packaging, logistics, pharmaceutical distributors, suppliers, medical institutions, pharmacies, online platforms, and the end users—patients or consumers. At every stage of this supply chain, the manufacture, transaction, supply, and use of counterfeit and illegal drugs, as well as the impact on life or bodily health resulting from the use of such drugs by patients or consumers, may give rise to various forms of tortious harm. Since such drugs are neither manufactured nor imported by licensed pharmaceutical companies and are not approved under domestic legal frameworks, any adverse drug reactions resulting from their use fall outside the scope of compensation under the Drug Injury Relief Act. Consumers who purchase these products through illegal channels often face great difficulty in presenting evidence, making legal recourse even more challenging.. Some consumers consider that they were defrauded after being misled by false advertisements, resulting in infringements of their interests, whether in terms of property or non-property losses. Even when counterfeit and illegal drugs are purchased through legitimate sales channels, consumers are nevertheless not eligible for drug injury relief, because such drugs remain classified as illegal drugs. If the parties are unable to reach a private settlement, disputes must be resolved through litigation under the Consumer Protection Act or the Civil Code. In the past, regulatory authorities primarily relied on customs inspections and border control to manage the illegal importation of counterfeit and illegal drugs. However, online shopping has now become a dominant channel for many products, and the circulation of counterfeit and illegal drugs is no longer limited to physical storefronts. Platform-based integration of online and offline transactions (not Foodpanda, but Drugpanda) has further fueled the cross-border spread of such counterfeit and illegal drugs. Although the Taiwan Food and Drug Administration continues to monitor online markets and educate consumers against purchasing medications from unknown sources, where there is demand, supply will follow. The increasing frequency of such transactions has rendered the threat posed by counterfeit and illegal drug crimes an ever-present and unresolved problem. Individuals who purchase counterfeit and illegal drugs through legal or illegal channels not only suffer financial loss and potential harm to their health, but may also face subsequent legal disputes. Regardless of the transaction model, the presence of counterfeit and illegal drugs gives rise to management costs, the burden on regulatory manpower, and impacts on national tax revenue, all of which constitute issues affecting the public interest of the nation. This study selects the topic “The Civil Liability of Torts for the Manufacture or Sale of Counterfeit and Illegal Drugs” to examine the scope of damage compensation available under existing domestic regulations when consumers inadvertently purchase counterfeit and illegal drugs through distribution channels. Through an analysis of current judicial practice and court decisions, the study further explores the relevant tortious acts and damage compensation arising from counterfeit and illegal drugs as incurred by suppliers and distribution partners within the upstream and downstream supply chain, as well as the resulting impact on end-user consumers. The study begins with the identification of a core problem associated with counterfeit and illegal drugs, and adopts a research methodology integrating literature review and judicial case analysis. Chapter 2 defines counterfeit and illegal drugs and their purchasing channels, thereby delineating the scope of tortious harm. Chapter 3 discusses the constitutive elements of tort liability in relation to such counterfeit and illegal drugs, including intentional and negligent tortious conduct, as well as the corresponding legal consequences, such as the “scope of compensation”, “punitive damages”, and “the burden of proof”. In Chapter 4, practical case analyses are conducted to examine the application of Articles 7 and 51 of the Consumer Protection Act and Articles 184 II, 194, and 195 of the Civil Code, as well as judicial perspectives and controversies concerning civil compensation in cases involving “loss of chance”, and the author’s views are presented accordingly. Finally, in Chapter 5, the study presents the conclusions and recommendations on legal reform. It further argues that the existing legal framework governing civil liability and tortious legal consequences arising from counterfeit and illegal drugs should be strengthened through legislative amendments and administrative regulation.