Research On Test Data Protection Of TRIPS Agreement

Pharmacon is a special commodity and the pharmaceutical industry is a special industry,which directly relate to human health, social stability and environmental protection. Most of the governments take measures to regular the pharmaceutical products market to ensure the safety and efficacy of pharmacon.As for approving the marketing of pharmaceutical products, governments usually require developers to submit"pharmaceutical test data"to prove the safety and efficacy of pharmacon. And meanwhile, there is huge commercial value in the test data. Therefore, article 39 item 3 of Agreement on Trade-Related aspects of Intellectual Property Rights (TRIPS agreements for short) prescribes that members shall protect such data against unfair commercial use and disclosure. However, the principled rule above aims to give freedom to members only supplies basic standard so members may make regulations according to their own circumstances.Through the theory analysis of data protection, explanation of article 39 item 3 of TRIPS agreements and references of foreign legislations, some proposals and countermeasures are put forward in accordance with present data protection situation and problems in China, hoping that they may be helpful to the public administration of pharmaceutical test data.This thesis is divided into several parts below:Chapter one: outline of data protection theory.Chapter two: explanation of pharmaceutical test data protection clauses in TRIPS agreement.Chapter three: foreign legislations on pharmaceutical test data protection.Chapter four: the present situation of pharmaceutical test data protection in China and some legislative proposals on this.Finally, a conclusion can be drawn that, according to the specific stage of development, our government should be cautious about the advantages and disadvantages of data protection, formulate and adjust the implementing regulations of pharmaceutical test data protection system in the Framework of TRIPS Agreement.