歐盟醫療器材法規改版對台灣生技產業股價影響之探討

Amendment of Medical Devices Regulations and Its Impacts on Stock Prices in Taiwan Biotechnology Industry

林榮茂(Jung-Mao Lin)

指導教授 ： 柯冠成

國立暨南國際大學/管理學院/高階經營管理碩士學位學程/碩士(2019年)

https://doi.org/10.6837/ncnu201900033

摘要

對生物科技產業而言，法規對公司的決策與營運扮演著相當重要的角色，多數國家針對此產業有相當明確的法規要求。由於法規的變動將造成公司投入成本的增加而影響其獲利，未符合法令將導致公司面臨觸法刑責及公司商譽的損失，進一步將會影響公司的股價表現。本研究之目的即在探討歐盟醫療器材法規改版對台灣生技業股價表現之影響，我們發現在此法規改版的過程，消息的宣告對台灣生技公司的股價有顯著為負的影響。進一步，由於生技業公司之營收大幅仰賴出口，我們將樣本公司區分為實驗組與對照組公司並進行實證，其中實驗組為經營形態或產品直接或間接受本次法規改版所影響之公司，而對照組則為經營形態或產品完全不受本次法規改版所影響之公司。結果發現兩種類型之公司在消息發佈後皆呈現顯著負向之異常報酬，顯示此次法規之變革不僅對實驗組公司存在顯著之影響，而對照組公司亦存在外溢效果。

關鍵字

生技產業 ； 醫療器材 ； 歐盟醫療器材法規

並列摘要

As most of the countries make certain regulations of Biotechnology, the regulation plays an important role in the company’s policy and operation. The companies will need to increase the cost due to the change of the regulations and it also impacts their margin. Those companies that don’t follow the regulations will face criminal punishment and the reputation will decrease as the result in. Furthermore, the stock price will be impacted. Hence, this research explores the influence on stock price in Taiwan Biotechnology industry with the amendment of EU medical device regulation. The results showed the announcement of regulation amendment has negative impact on stock price in Taiwan Biotechnology industry. Furthermore, since turnover of Biotechnology industry comes from exportation, experimental group and control group were surveyed. The results showed us after the announcement of the regulation amendment, the stock price of these two groups all has a negative abnormal return. The study concluded that the amendment of EU medical device regulation influenced not only the stock price of experimental group but also control group.

並列關鍵字

biotechnology industry ； medical device ； EU medical device regulation

參考文獻

一、英文參考文獻

1. Hill (1990), National Technology Strategies, in John de la Mothe and Louis Marc Ducha-rme (eds.), Science, Technology and Free Trade, London: Pinter, pp. 95.

2. Robert, E. B. & Mizouchi, R. (1989), “Inter-firm Technological Collaboration: The Case of Japanese Biotechnology”, International Journal of Technology Management, Vol. 4(1), pp. 43-61.

二、中文參考文獻

1. 林盈甄（2013）。台灣生技醫療產業經營績效評估-灰關聯分析法之應用，長榮大學國際企業研究所學位論文，台南市。