Research On Legal Standard Of Generic Drug In-transit

In recent years, the EU customs authorities, according to the regulations ofin-transit goods in The Council regulation (EC) No.1383/2003, frequently detainedthe in-transit goods exported to non-EU countries from India for alleged infringementof intellectual property rights. In the meantime, the nations that are powerful inintellectual property have a shift in negotiation, aiming to increase protection strengthon intellectual property, and board measures are first to be noticed. TheAnti-Counterfeit Trade Agreement(ACTA) and Trans-Pacific PartnershipAgreement(TPP) are shaking the law enforcement system of intellectual propertyunder the WTO multilateral framework. Following the ACTA, The Council regulation(EC) No.608/2013also increases its protection strength on the board measures ofintellectual property. To specifically analyze the changes of standards of the in-transitlegality and to look into its causes helps to promote the developing and the leastdeveloped countries to establish the legal standards of free transit on the basis ofWTO/TRIPS.This thesis is divided into four chapters:Chanpter One demonstrates that under the system of WTO/TRIPS, the legalstandard of in-transit generic drug is freedom in transit. The first quarter concludes themain legal disputes of the case of India’s generic drugs which are detained by the EU.The second quarter questions the legality of The Council regulation (EC)No.1383/2003, which is about board measures applied to in-transit goods. Starting from the legal basis of EU’s in-transit restrictions, combined with the judicial practice,the transit restrictions are analyzed under the WTO framework, and is thought to beagainst the regulations of transit legal standard in GATT1994and the aim of avoidingestablishing the legal barriers to trade in TRIPS.Chapter Two is a micro-analysis of the changes of legal standards of in-transitgeneric drugs as well as its trend. The first quarter refined the high-standard in boardmeasures of Anti-Counterfeit Trade Agreement(ACTA) and Trans-Pacific PartnershipAgreement(TPP), and a comparison is made with the TRIPS. The second quarterdiscusses the changes of legal standard in the domestic law level. The Councilregulation (EC) No.608/2013is studied and a horizontal comparison is made with theThe Council regulation (EC) No.1383/2003and ACTA, concluding that the changesof the legal standards of in-transit generic drugs are realized by the policies of thepowerful intellectual property countries by establishing international agreementpermeating the member countries’ domestic laws.Chapter Three is a macro-perspective on the causes of the TRIPS-Plus legalstandard of in-transit goods. The first quarter focus on the international negotiationsystem, and propose a vertical analysis on the change of tactics the developedcountries used to reaching international agreement, following the historicalnegotiating orbit which starting from the multilateral system to the bilateral system tothe plurilateral one coexisted with the bilateral one, and a combination of the ACTAand TPP. The second quarter analyze the political aim of the developed countries andthe situation of the main negotiating members in TPP, including the main transitcountreis.Chapter Four generalize the position of China and the measures it should take, asa major exporter of generic drug, faceing with the change of transit legal standard.Strictly assurance should be advanced in legal system. China should join othersinternationally, control the pace of cooperation in East Asia and take advantage of theWTO/TRIPS system positively to ensure the discourse right.