萬國法律事務所

The draft bill for the amendment of the “Act for the Development of Biotech and New Pharmaceuticals Industry” was blocked at the first reading at the Legislative Yuan after certain legislators called into question whether the government had been pressured by the industry to relax the qualification criteria for tax benefits under the Act. As a result, on November 4, 2010 the Economic Committee of the Legislative Yuan decided to temporarily hold off on the review and called for a public hearing and discussion.

Under the draft bill, the Ministry of Economic Affairs (MOEA) proposed to amend the definition of ‘High-risk Medical Device’, which may result in tax benefits offered under the Act due to the change from “a type of Class III medical devices implanted into human bodies” to “a type of Class III medical devices”.

Officials of the Industrial Development Bureau of the MOEA indicated that, since the enactment of the Act in 2007, only a total of five medical device manufacturers qualified for the tax benefits offered under the Act, and that it was clear that the qualification threshold for medical device was too high. As such, the Bureau proposed to relax the qualification criteria by removing the element of “implanted into human bodies”. Once removed, tax benefits may be obtained for medical devices such as agents in vitro, medical electronics and contact lenses and the like. However, certain legislators commented that amending a law enacted as recent as 2007 to relax the qualification criteria for tax benefits will raise suspicions that the MOEA had been pressured by the industry to do so, and suggested that the public’s input and opinion should be heard at a public hearing before the draft bill is reviewed.