建構我國學名藥法制之研究

Abstract

我國法制中與學名藥相關法規甚多且屬不同部會之立法職權。立法之時，部會間立場不同，個別立法造成法規適用之分歧，法院在藥品專業不足下，往往做出另人惋惜之結果。學名藥是社會公益之極大表現，當學名藥進入市場後，民眾即能使用安全有效均一但經濟之藥品，學名藥能大幅降低各國政府之醫療財政負擔，因此亦符合整體之世界潮流。台灣之製藥產業雖均為學名藥製造業，但卻提供七成以上之服務護衛國人健康，其相關製藥水準也已達世界衛生規範，因此鼓勵使用國產學名藥亦能符合促進國內產業發展之美意。因此，基於台灣為成文法之國家，以符合世界潮流之精神訂定符合社會公益兼具我國製藥產業發展的專責學名藥法實為必然之趨勢。 依據本文所探討之各項要點，學名藥法應包含但不限於以下幾大重點： 1. 明確定義學名藥。 2. 學名藥法相對於其他各法律之特別位階：包括但不限於以下法規： (1) 專利法：學名藥進藥試驗包括於試驗免責範圍之內。 (2) 著作權法：明定藥品仿單不侵犯著作權。 (3) 藥事法：賦與資料專屬權應伴隨適當資料的揭露義務；並建立類似美國橘皮書制度。 (4) 全民健康保險法：健保之藥費給付宜以學名藥為主，其餘藥品差價則由使用者負擔；且明定學名藥自動取代機制，讓藥品差價之選擇權回歸消費者，以防堵各種可能之浪費情形。 3. 本研究顯示有許多可能存在之專利權「故意濫權」之態樣，基於「故意侵權」已立法規範嚇阻；為平衡立法，「故意濫權」亦應相對立法嚇阻。 期望本文能得到立法及政府當局之了解及認可，進而經由立法達到完善社會公益之保護，促進我國製藥工業之持續發展，又不違世界潮流。世上多數國家之製藥產業及市場環境與我國類似，這些國家亦無整體化之學名藥法制。同時也冀望本文初探式拋磚引玉，引起更多詳盡討論，導出不限於我國社會所需相關學名藥之公平立法。

There are many laws and regulations related to the generic drugs in Taiwan. Every legislation of them governed by the different Departments at the Executive Yuan. Looking at generic drug at diffenent angle and lack of complete communications, each Department independently legislates dicrepant Laws or Regulations. Following this, the Court, without enough pharmaceutical expertise traning, often made a decision which might be contrary to the public interest. Generic drugs represent the maximum appearance of the public interest. People could enjoy the safe, efficious, consistent and economic generic drugs when they could legally launch to the market. Generic drugs also save a lot of medical insurance expense for every countries and it is becoming the trend of the world to promote them in health reform. Although the majority of local pharmaceutical industries are making generic drugs, they serve more than seven-tenth of the durg comsumption and protect the people of Taiwan from dieasese. In addition, the manufacturing standard in Taiwan Pharmaceutical manufacturers are all reaching the world class. To encourage the use of local generic drugs also fulfills the goal of developing local industries. Since Taiwan is of statute law system, therefore, in accordance to the world trend to legislate a Law of Generic Drug for Taiwan should be considered. The study suggests The Law of Generic Drug should include but not limit to the following Regulations: 1. The definition of Generic Drug should be suitably re-defined. 2. The Law of Generic Drug should be considered as the special Law to but not limit to the following regulations: (1) Patent Law: The listing Trial of Generic Drugs should literally be exempted from Patent Right; (2) Copy Right Law: The insert of Generic Drug should literally be exempted from Copy Right; (3) Law of Pharmaceutical Affair: Data exclusivity protection should be compensated with disclosure of relative information; Orange Book should be established; (4) Regulations to the National Health Insurance: For the sake of reducing financal burden, the generic drugs should be the first line of medication. The price difference between the generic drugs and any branded drugs should be the burden of users. The auto-substitution of generic drugs to branded drugs should be the right of user as they will pay for the price difference. 3. The study has also shown that there are many types of possible “willful misuse” of the Rights. As “willful infringement” has already been written in the Law, therefore a written Law to prevent “willful misuse” of the Rights should also be established to balance the legistration at Taiwan. The study sincerely hopes that the Legistrative and Government authourities could understand and appreciate the deficiencies, comments and suggestions regarding the existing regulations at Taiwan. The environment of pharmaceutical industries and market of many countries are similar to Taiwan. These countries also do not have an integrated Law to regulate Generic Drugs as well. The study also hopes it will incur more discussion and eventually the Law of Generic Drug could be enacted in Taiwan and also sets a legislation model for the rest of the countries like Taiwan.