| Pharmaceutical is different with general merchandise because it is closely related to the health of human beings.So countries have implemented a strict administration approval and supervision system for drug approval,and the development of pharmaceutical industry is highly susceptible to the relevant legal system.In order to ensure that the public can obtain generic drugs at a low price,most modern countries have established abbreviated new drug application(ANDA)for approval of generic drug,and generic drug manufacturers were no long required to submit pharmaceutical test data which has been submitted by original drug manufacturers to prove effectiveness and safety of drugs during the approval application.But ANDA may cause free-side of generic drug manufacturers,and it will infringe upon interest of original drug manufacturers who invested a lot in preclinical trials and clinical trials.Therefore,most countries established a system of pharmaceutical test data protection.Pharmaceutical test data protection originated in developed countries such as the United States and the European Union.And the TRIPs Agreement including pharmaceutical test data into the international intellectual property protection regime for the first time historically.After the TRIPs Agreement came into effect,members of WTO began to develop domestic law based on pharmaceutical test data protection of the TRIPs Agreement.However,due to the particularity and the disputes on legal character of pharmaceutical test data,coupled with the ambiguity of Article 39,paragraph 3 of the TRIPs Agreement,there are many differences in domestic legislative between different countries.Some countries chose data exclusivity while others regarded pharmaceutical test data as undisclosed data.With the advancementof society and the development of technology,TRIPs –Plus standard with greater scope and stronger protection has emerged.However,many developing countries still have negative attitude against high-standard pharmaceutical test data protection in accordance with actual national conditions and structure of pharmaceutical industry.Therefore,there is no authoritative or unified institutional system of pharmaceutical test data protection has been formed in theory or practice.Theoretically,protection of pharmaceutical test data has triggered new theoretical problems,leaving a gap in a unified and authoritative system.Clarifying the relationship between pharmaceutical test data protection,protection of trade secret and traditional intellectual property protection can help us to establish a new independent institutional system.Pharmaceutical industry is an important part of international economic trade,research and improvement of pharmaceutical test data protection is of great significance to the entire pharmaceutical industry and even development of society.What’s more,as an emerging country about pharmaceutical industry,China has very good prospects for development in pharmaceutical market.However,most relevant provisions of pharmaceutical test data protection in China are vague and lack of maneuverability.China urgently needs a well-established pharmaceutical test data protection system which is in line with national conditions and development.This dissertation aims to study on international protection of pharmaceutical test data.Followed by a brief introduction of issues and the necessity of this research,the dissertation will discuss this topic in five chapters.Chapter One is an overview of conceptions of pharmaceutical test data protection and discusses the theoretical issues about pharmaceutical test data protection.There is no authoritative and unified theoretical system of pharmaceutical test data protection.Chapter Two mainly studies the domestic legislation of pharmaceutical test data protection in different countries.By comparing the differences in pharmaceutical test data protection in different countries,it reflects the impact of theoretical problems on practice.Chapter Three analyses the international obligation established by the TRIPs Agreement to protect pharmaceutical test data.Chapter Four is focused on the development trends of pharmaceutical test data protection from Trans-Pacific Partnership Agreement and free trade agreements after enforcement of the TRIPs Agreement.These two chapters summarize the current status of international protection and the development trends of pharmaceutical test data protection by analyzing provisions about pharmaceutical testdata protection from the TRIPs Agreement,the TPP Agreement and FTA.Finally,Chapter Five discusses the pharmaceutical test data protection in China.In order to fulfill international obligations,China should improve the relevant laws and regulations based on the conditions of pharmaceutical industry.The pharmaceutical test data protection in China should encourage the innovation of pharmaceutical as well as the development of generic drugs. |
