A Study on the Construction of Generic Drug Regulations of Taiwan
|關鍵字:||學名藥;專利法;著作權法;藥事法;全民健康保險法;故意濫權;社會公益;Generic Drug;Patent Law;Cpoy Right Law;Pharmaceutical Affair Law;National Health Insurance Law;Willful Misuse;Public Interest|
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.
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