藥品資料專屬權,一直是國內外藥廠非常重視的議題,涉及到學名藥廠與原開發藥廠龐大市場競爭利益,美僑商會2009年及2010年白皮書都一直列有建議我國政府應立法新適應症資料專屬權之保護。主管機關行政院衛生署面臨此項課題的做法係在87年7月17日衛署藥字第87041668號公告,以及99年12月9日修正藥品查驗登記審查準則第54條第3項,規定首家申請新適應症廠商執行國內臨床試驗而獲核准,在新藥安全監視期間(自發證日起七年)或第二家申請相同成分、劑型、劑量許可證,除依現行規定檢附相關資料外,應另檢附與首家申請廠商相同標準之國內臨床試驗報告,上項規定是否有牴觸藥事法第40-2條而無效以及如給予新適應症資料專屬權保護,保護期應多長等問題是本文探討主題。本文參考國外對於新適應症資料專屬權保護規定以及法律優位原則,國內製藥界以及人民用藥權益等因素,認爲87年7月17日衛署藥字第87041668號公告,以及99年12月9日修正藥品查驗登記審查準則第54條第三項規定有牴觸藥事法第40-2規定而無效,建議衛生主管機關應另爲適法之處置。如有必要給予新適應症資料專屬權保護應修改藥事法明確規定其法源以資適法,至於保護期間與條件,則宜規定須在國內進行臨床試驗經獲准者始有二年保護期,以兼顧國內製藥界發展與人民用藥權益。
Pharmaceutical data exclusivity is a critical issue to both multi-national and domestic local pharmaceutical companies due to huge competitive market potential interest. In 2009 and 2010 White Paper released by American Chamber of Commerce in Taiwan (AmCham), AmCham explicitely recommends Taiwan Authority to amend Pharmaceutical Affair Act to protect the interlectural property right, data exclusivity, of pharmaceutical new indication. In responce to this request, Department of Health has amended Article 54, Sec.3 of Guidance of Pharmaceutical Registration and Approval on December 9, 2010 to reiterate Pharmaceutical Affair Notification 87041668 issued on July 17, 1998. It states that the second pharmaceutical firm who applies same active ingredient, same dosage form and dosage should, in addition to all the reguired relevent documentation, submit the same standard clinical trial report as the first approved new-indication applicant with execution of local clinical trial under the new drug surveilence period (7 years after licencing). After examing the comparatory relevent international law and the concept of upper law with superior priority, the authors have come to the conclusion that the above regulation infringes Article 40-2 of Pharmaceutical Act and becomes invalid. If indeed the State wants to grant the data exclusivity protection for pharmaceutical new indication, we recommend to officially amend the Pharmaceutical Act to comply with the judiciary due process. As for the appropriate protection terms and period, the authors recommend to grant 2-year protection time with execution of local clinical trial to balance the interests between pharmaceutical industry development and the general public.