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題 名 | WTO醫藥專利與公共健康議題之研析--兼論我國未來之發展趨勢=Analysis on WTO Pharmaceutical Patent and Public Health Issues with Particular References to Future Trends in Taiwan |
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作 者 | 林宜男; 許佳惠; | 書刊名 | 清華科技法律與政策論叢 |
卷 期 | 2:1 民94.03 |
頁 次 | 頁205-257 |
分類號 | 440.6 |
關鍵詞 | 世界貿易組織; TRIPS協定; 公共健康; 強制授權; 醫藥專利; 專利法; 杜哈部長會議; 愛滋病; WTO; TRIPS agreement; Public health; Compulsory licensing; Pharmaceutical patent; Patent law; Doha ministerial conference; AIDS; |
語 文 | 中文(Chinese) |
中文摘要 | 近年來,由於治療愛滋病藥物之專利保護要求,使得醫藥價格居高不下;遂使諸多貧窮國家無法取得所需醫藥品,導致其國內領域公共健康危機。南非與巴西政府為解決其國內日益嚴重的愛滋病問題,而就醫藥品專利行使強制授權後,旋即引起歐美先進已開發國家大藥廠不滿,因而提出控訴,使得藥品專利與公共健康間之衝突性爭議,頓時白熱化起來。除WTO各會員國極力主張應有效解決此問題外,諸多國際組織與非政府組織,如世界衛生組織、聯合國經濟社會理事會架構下之人權保障及促進次級委員會、聯合國貿易發展會議等,亦大聲疾呼WTO應正視開發中國家與低度開發國家所遭逢的公共健康危機。 2001年9月,WTO於卡達杜哈所舉行的第四屆部長會議,有鑒於解決藥品專利與公共健康問題之聲浪日益高漲,遂於其杜哈部長宣言第十七段中宣示,TRIPS協定之解釋與執行,應藉由提倡用藥權與新藥之研發,以有利於保障公共衛生之方式為之;由此可知,藥品專利與公共健康問題已成為杜哈部長宣言欲解決之主要問題之一。2001年11月14日,WTO於杜哈部長宣言之外,針對公共健康議題,制定通過「TRIPS協定與公共健康宣言」。嗣後,WTO會員便於2003年8月通過「觀於TRIPS協定與公共健康之杜哈宣言第六段之執行決議」,是項決議同意准許開發中國家設立進口愛滋病、瘧疾、肺結核等之廉價藥品制度。 揆諸我國專利法之規定,其第76條中亦規定有專利強制授權(特許實施)之規定:為因應國家緊急情況或增進公益之非營利使用或申請人曾以合理之商業條件在相當期間內仍不能協議授權時,專利專責機關得依申請,特許該申請人實施專利權;其實施應以供應國內市場需要為主。依據WTO現行之國際規範,強制授權所生產之藥品,已不再受限於必須以供應國內市場需要為主,對此,我國現行專利法有關強制授權之相關規範,應與國際潮流接軌,參酌WTO最新修正決議予以修正之,建立完善的藥品專利授權制度,俾保障我國自身應有之權益。 |
英文摘要 | In recent years patent protection requirements for AIDS medicines have led to high prices, made it hard for poor countries to acquire the necessary drugs, and contributed to a public health crisis in these countries. The decisions by South African and Brazilian governments to enforce compulsory licensing for AIDS medicines have antagonized pharmaceutical corporations in the EU and the USA. These companies have filed lawsuits and have made a heated issue of this conflict between pharmaceutical patent and public health. Member countries of the WTO have strongly urged the resolution of this problem. International organizations and non-governmental organizations like the WHO, the committee for the Protection and Improvement of Human Rights under the United nations Economic and Social Council, and the United Nations Conference on Trade and Development have also urged the WTO to deal with the public health crisis in developing and less developed countries. In September, 2001, during the Fourth Ministerial Conference of the WTO held in Doha, in view of the increasing concerns over resolving the conflict between pharmaceutical patent and public health, paragraph 17 of the Doha ministerial Declaration provides that the interpretation and implementation of the TRIPS Agreement should be carried out in a way that encourages the user rights of medicine and the development of new drugs, and helps ensure public health. This shows that pharmaceutical patent and public health have become a major issue that the Doha Declaration seeks to resolve. On November 14, 2001, the WTO has, in addition to the Doha Declaration, formulated and passed the “Declaration on the TRIPS Agreement and Public Health”. Therefore, WTO members passed “Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health” in August, 2003, which allows developing countries to establish a system of importing cheap drugs for AIDS, malaria, TB and other diseases. Article 76 of Taiwan’s Patent Law contains provisions for compulsory licensing on Patent (as exceptions). Under this Article, in times of national-wide emergencies, or for the non-profit usage that improves public interests, or when the applicant has, after a reasonable period of time and under reasonable business conditions, still not been able to negotiate for the licensing, the relevant authorities for patent regulation could give exceptional agreement to the applicant to use patent rights. Such usage should mainly be limited to the domestic market. According to the WTO’s present international provisions, the drugs under compulsory licensing are no longer limited to mainly domestic market. Therefore the relevant provisions in our country’s present patent law on compulsory licensing should be amended to accord with the latest WTO amendments. So that an improved pharmaceutical patent licensing system should be established to protect our country’s rights and interests. |
本系統中英文摘要資訊取自各篇刊載內容。