查詢結果分析
相關文獻
- 由美國立法經驗探討促進兒科試驗暨兒科用藥研究之合理措施
- 資料專屬權與專利保護制度之競合:以美國藥品上市法制為中心
- 論我國專利期間的調整與延長、資料專屬權與專利連結制度之發展現況--藥品智慧財產權保護相關修正草案評析
- 我國藥品專利保護之現況與未來--從專利連結制度之研擬談起
- Protection of Test Data of Prescription Drugs under TRIPs
- 以比較法觀點探討罕見疾病孤兒藥誘因
- 論專利權之性(上)--彰化地院及其上訴審臺中高分院專利侵害刑事判決評釋
- 論專利權之性質(下)--彰化地院及其上訴審臺中高分院專利侵害刑事判決評釋
- 專利權人發警告信函是否觸犯公平交易法第二十四條之檢討
- 中國大陸專利權欺詐之態樣分析
頁籤選單縮合
題 名 | 由美國立法經驗探討促進兒科試驗暨兒科用藥研究之合理措施=To Study the Reasonable Measures of Improving Pediatric Clinical Trials and Drug Research from the U.S. Legislation Experience |
---|---|
作 者 | 陳文吟; | 書刊名 | 高大法學論叢 |
卷 期 | 9:1 2013.09[民102.09] |
頁 次 | 頁107-111+113-166 |
分類號 | 412.24 |
關鍵詞 | 專利權; 兒科臨床試驗; 兒科研究; 兒科評估; 資料專屬權; 市場專屬權; 罕見疾病; 孤兒藥法; Patent rights; Pediatric clinical trials; Pediatric study; Pediatric assessment; Data exclusivity; Marketing exclusivity; Rare diseases; Orphan drug act; |
語 文 | 中文(Chinese) |
中文摘要 | 西元 1968 年Harry Shirkey 醫生著文,謂兒童是醫療上的孤兒,至今已45 年,兒童依舊是醫療上的孤兒。主要原因為兒科用藥市場有限、兒科臨床試驗的困難,藥廠在評估損益後,多選擇放棄兒科市場,不從事兒科臨床試驗。專利權利的賦予,已公認係促進研發、提升產業科技與改善人類生活和健康的必要措施;然而,專利制度未必能克盡其功。 |
英文摘要 | In 1968, Dr. Harry Shirkey pointed out Children are therapeutic orphans. As to the study of approved drugs, only 25% to 30% of them included pediatric data that could be approved to indicate children’s doses, safety and efficacy on the labels. Other than that, physicians prescribe off-label drugs to children. Lack of doses and safety information causes our children exposed to severe adverse effects and sometimes receive inefficient treatment. Children are different from adults, not on the height or weight, but on the bodies, such as drug metabolism, brain development, immunological systems and organ systems. To prescribe adult drugs to children without pediatric clinical trial information is risky. U.S. Congress enacted pediatric related legislation such as PBCA and PREA, the former encourages pharmaceutical companies to conduct pediatric study by offering six-month marketing exclusivity, and the latter forces pharmaceutical companies to conduct pediatric assessment. FDA marketing exclusivity caused many adult patients great burden for medical expenses, but created little benefits to children. In our country, there isn’t any law relating to pediatric medication. Having studied American legislation, the author concluded that PBCA- like legislation should not be recommended, but, suggested the following measures to improve our pediatric drugs: 1. to adopt PREA-like legislation, forcing company to conduct pediatric study; 2. to encourage pediatric drug use invention by providing new use invention patents. |
本系統中英文摘要資訊取自各篇刊載內容。