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題 名 | Note on the Anti-Counterfeiting Trade Agreement: Double-edged Sword on Pharmaceutical Access?=簡析「反仿冒貿易協定」對藥物近用之影響 |
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作 者 | 鄭莞鈴; | 書刊名 | 科技法律評析 |
卷 期 | 4 2011.12[民100.12] |
頁 次 | 頁249-281 |
分類號 | 579.93 |
關鍵詞 | 反仿冒貿易協定; 假藥; 學名藥; 雙邊自由貿易協定; Anti-counterfeiting trade agreement; ACTA; Counterfeit medicines; Generic pharmaceutical access; Free trade agreements; FTAs; |
語 文 | 英文(English) |
中文摘要 | 有鑒於假藥於開發中國家的猖獗現象,三十七個國家透過多邊協議的方式草擬了反仿冒貿易協定(Anti-Counterfeiting Trade Agreement, ACTA),該協定要求各會員國須採取暫時與永久禁制令,以杜絕侵害他人智慧財產權之侵權藥品或原料流入國際市場通路。然而,此一最新形態的國際智慧財產權法制,儘管專利權不在其規範範圍內,在打壓假藥的同時,仍可能阻絕學名藥的合法通路。原料藥供應商或藥品採購與運送業者將因可能因面臨藥品被扣押或查封等重大經濟損失,甚或刑責,而不願鋌而走險為急需藥品的國家提供學名藥。甚言之,反仿貿易協定中備受爭議的第三方執行更可能無限擴張,無論進口或出口國於其雙邊自由貿易協定中是否有資料專屬權的保護規範,只要進出口途中經過的運送國有資料專屬權的規範,該藥品途經該運送國時即可能逕行扣押。於此,迫切需要學名藥的進口以解決瘧疾與愛滋病等開發中國家,其藥量不足的困境恐將難以獲得改善。故,於法的解決之道則應為謹慎地適用反仿貿易協定,於防止假藥進入流通市場之際,也能同時確保學名藥的通路不受阻礙。 |
英文摘要 | In response to the prevalence of counterfeit drugs in developing countries, the Anti-Counterfeiting Trade Agreement (ACTA) being negotiated plurilaterally by 37 countries would require members to provide preliminary and permanent injunctive relief against third parties, known as third-party enforcement, to block infringement of intellectual property rights of right holders and to prohibit infringing goods or materials from entering into the commerce channels. Even though patent rights are excludable in the ACTA, the new globalized forms of third-party enforcement would still threaten the legitimate trade of generic pharmaceutical access. By imposing third-party enforcement1 and preliminary/permanent injunctions, active pharmaceutical ingredient suppliers, transporters and other actors in the global procurement and supply of medicines could would likely face the risk of injunctions, provisional measures, and even criminal penalties, and therefore might be reluctant fund and facilitate procurement of generic medicines or even transport lawful medical products through countries where ACTA signatories involve. Even further afield, by extending third-party liability in the ACTA, the data exclusivity provisions in bilateral free trade agreements (FTAs) could be invoked by a transshipment country’s customs authorities as a basis for seizing in-transit pharmaceutical products, even if there is no data exclusivity in the exporting and importing countries. Obviously, this great risk burdens generic exporting countries in preventing the access to medicines to developing nations where affordable generic drugs are needed in vast quantities to combat commonly widespread diseases, such as malaria and HIV/AIDS. An effective solution to combat counterfeit pharmaceuticals without hampering access to generic medicines, therefore, would be to narrowly construe the ACTA to stick to its text providing that barriers to legitimate trade should be avoided. Part I of this note explores the global recognition of the public health crisis arising from the prevalence of counterfeit pharmaceuticals, as well as the concerns over the involvement of organized crime and terrorism. Desiring to combat the proliferation of counterfeit goods and services, complementing the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), the negotiations of the ACTA therefore commenced. Part II of this note explains the key provisions of the ACTA which create an international cooperation mechanism through criminal enforcement, civil enforcement, and border measures, to effectuate the objectives that ACTA seeks to promote. Part III discusses the how the various ACTA provisions would threaten active pharmaceutical ingredient suppliers, transporters, procurement agents and even regulatory authorities and further constrain access to generic medicines, contrary to what the ACTA negotiators claimed. Part IV further analyzes how the ACTA may supplement the data exclusivity provisions in FTAs to act as a significant constraint on developing countries’ pharmaceutical exports. |
本系統中英文摘要資訊取自各篇刊載內容。