原開發藥廠新藥上市程序與其智慧財產權保護功能之初探

Abstract

本研究主要就原開發藥廠新藥的上市程序及新藥上市程序中隱含智慧 財產權保護的功能進行研究。 民國82年7月7日衛生署公告「新藥安全 監視制度」其中明確要求申請新藥查驗登記應另檢附國內臨床試驗報告資 料，爾後又公告公立醫院不得要求進行以進藥為目的的臨床試驗，民國83 年3月1日政府宣布實施全民健康保險，為期全民健保永續經營，藥品的核 價原則將逐次建立以臻於藥價合理化。 本研究依查驗登記用臨床試驗 申請書送至衛生署，衛生署核發藥品許可證，及中央健保局核准該新藥的 健保給付價格與使用規範，將新藥上市分成「查驗登記前期」、「查驗登 記時期」、「部份上市時期」及全面上市時期」等四個時期，並整理得知 「查驗登記用臨床試驗」、「健保新藥的核價」、及「醫院的進藥」為新 藥上市程序中三個令人關切的重點，除在其間探討智慧財產權保護的功能 外，並試圖提出兼顧國內利益保障的可行課題。 The thesis is focused mainly on the launch process of new drugs supplied by original pharmaceuticals, as well as the protective function of intellectualproperty rights related to them. On July 7, 1993, Department of Health (DOH) published the "New Drug surveillance System" which stipulates that applicat ions for registration for new drugs should be filed together with reports of domestic clinical trials. A later addition to this document stipulated that local hospitals are not permitted to carry out clinical trials for the purposes of deciding whether or not to list new drugs. It is expected that the National Health Insurance (NHI) program implemented on March 1, 1994 will help establish easonable drug pricing system under the price reimbursement policy. The thesis presents a program for a four-stage launch process: 1.Pre-registration stage 2.Registration stage 3.Partial launch stage 4.Complete launch stage This has been decided in accordance with the drug license issued by the DOH based on the application for registration trials, as well as the reimbursement price and guidelines for use issued by the Bureau of National Health Insurance. From the investigation and understanding of the thesis, the three critical points related to this launch process include: 1.Registration trials 2.Reimbursement price of new drugs used in the NHI 3.Hospitals' listing policies In addition to the protective function of intellectual property right, this discussion will also address the feasibility of taking care of local people's interests.