ETTO Ask For Data Exclusive Rights on New Drugs.

E031009Z9 Nov. 2003（E48）

Upon the time when a lot of large international pharmaceutical factories are said to invest in Taiwan, European Economic and Trade Office (ETTO) today will visit the Department of Health (DOH), Taiwan, R.O.C., offering the suggestion regarding the law amendment like “Six-year data exclusive rights of the clinical research on new drugs”. Once the law of “data exclusive rights” is made and passes, we will permit the pharmaceutical factory first obtaining the license of new drugs to enter the market with “six-year market monopoly rights”, which will have impact on the benefit of many generic companies and the issue like drug price adjustment of health insurance. Besides the law amendment that six-year protection of “data exclusive rights” should be given to the said pharmaceutical factories alike, the suggestions proposed by ETTO also included that DOH should stop offering the information like clinical trial protocols to generic companies.

    It is known that the attitude of DOH toward this topic in the past tended to encourage the pharmaceutical factories to seek for the 20-year-valid-period patent protection. Compared with the seizure of the drugs infringing the patent right in the market, it is more beneficial for the companies if the government directly impedes the competitors from entering the market.
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