法學期刊.
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論著名稱: 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)
編著譯者: 陳文吟
出版日期: 2013.09
刊登出處: 台灣/國立高雄大學法學論叢第 9 卷 第 1 期 /107-166 頁
頁  數: 50 點閱次數: 787
下載點數: 200 點 銷售明細: 權利金查詢 變更售價
授 權 者: 國立高雄大學法學院 授權者指定不分配權利金給作者)
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
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,已公認係促進硏發、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。
用於兒科病患的已上市藥品或非專利藥品,仍無強制力或誘因促使 藥廠進行兒科硏究。
鑑於美國立法的優點及缺失,以及鼓勵硏發新的兒科用藥之不易,本文建議以下列方式鼓勵兒科硏究與兒科用藥的硏發:1. 於藥事法中明定新藥之取得上市許可應檢附兒科硏究資料;倘原藥廠因正當事由無法從事兒科硏究,食管局得依職權委託或依申請由第三人進行硏究。2. 以專利制度之用途發明專利,鼓勵藥廠就已上市藥品及非專利藥品從事硏發兒科用藥之新用途,提升兒科病患之醫療品質。

英文關鍵詞: Patent RightsPediatric Clinical TrialsPediatric StudyPediatric AssessmentData ExclusivityMarketing ExclusivityRare DiseasesOrphan Drug Act
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.

目  次: 壹、前言
貳、兒科用藥與兒科臨床試驗
一、兒科用藥的欠缺與重要性
二、兒科臨床試驗的困難
參、美國立法例
一、1997年FDA現代化法
二、最佳兒童醫藥法
三、兒科研究平等法
四、BPCA與PREA之評析
肆、我國法制及鼓勵兒科用藥研發因應措施
一、藥事法之增訂兒科研究要件
二、用途發明專利
伍、結語
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