生技新藥產業發展條例對生技新藥公司之助益

Abstract

生技新藥產業雖為高風險產業，但因其為報酬率較高且較不受經濟景氣影響的產業，因此許多國家目前都積極推動生技新藥產業的發展，而我國也從1980年代陸續頒布「加強生物技術產業推動方案」、「臺灣生技起飛鑽石行動方案」及「臺灣生技起飛行動方案」推動臺灣生技新藥產業的發展。總統府並於96年7月4日制定公布「生技新藥產業發展條例」，鼓勵廠商投入生技新藥開發。也因此，台灣的生技新藥產業廠商目前也逐漸茁壯，並逐步邁向開花結果的階段。 生技新藥產業發展條例以提供技術、人才及資金等租稅優惠措施，鼓勵廠商投入生技新藥開發，也對扶植生技新藥產業扮演著重要的角色。但在廠商實際申請適用生技新藥產業發展條例的過程中，卻因為條例本身規定的不完整或是國稅局本身對條例解釋較為嚴謹之關係，造成廠商無法完整取得各項優惠。因此本研究藉由針對生技新藥產業發展條例的法條本身內容、立法源由及說明以及法條之優缺點逐條加以分析及探討。另外再訪談並徵詢生技新藥業界專家對生技新藥產業發展條例對生技新藥公司經營發展或是對生技新藥從業人員的影響之意見，最後加上個人本身之相關經驗加以記錄後，提出對生技新藥產業發展條例的建議。此外，因在研究的過程中，生技新藥產業專家們也提出他們對其他法令或制度的改善建議，因此在本研究中也一併記錄，並彙總於結論與建議中，以供未來修法之參考。

The biotech and new pharmaceuticals industry involves high risks. However, many countries are actively promoting the development of the biotech and new pharmaceuticals industry due to its high rate of return and small impact of the economic development. In Taiwan, the government announced the “Action Plan for Biotechnology Industry”, “Taiwan Biotechnology Take-off Diamond Action Plan”, and “Taiwan Biotech Industrialization Take-off Action Plan” in succession since the 1980s, in order to promote the development of the biotech and new pharmaceuticals industry. On July 4, 2007, the Presidential Office announced the “Act for the Development of Biotech and New Pharmaceuticals Industry”, which encourages companies to invest in the development of biotech and new pharmaceuticals. As a result, companies in Taiwan's biotech and new pharmaceuticals industry are developing and growing stronger at the present, and gradually stepping into the stage of maturity. The Act for the Development of Biotech and New Pharmaceuticals Industry provides incentives to biotech and new pharmaceuticals companies by providing technology, talents, capital, and other tax preferences, thus playing an important role in supporting the development of the biotech and new pharmaceuticals industry. However, biotech and new pharmaceuticals companies cannot obtain the full benefits in the process of actual application due to the imperfect of the Act itself or the strict explanations of the Act by the National Tax Bureau. Therefore, this study aims to conduct detailed analysis and discussion of the contents of the Act, the reasons for legislation, as well as the advantages and disadvantages of the articles in the Act. In addition, some experts in the biotech and new pharmaceuticals industry will be interviewed and consulted for advice regarding the effect that Act makes on employees in this industry, or on the operation and development of biotech and new pharmaceuticals companies. Finally, some relevant experience from the author of this study will be recorded and the suggestions will be proposed regarding the Act. In addition, experts in the biotech and new pharmaceuticals industry also propose some advices on the improvement of other laws and decrees during the interview of this research. These advices are recorded and summarized in the conclusion and suggestions of this study for reference of future amendment of the Act.