Technical Barriers To The Internationalization Of Chinese Medicine And Its Legal Countermeasures Research

The strategic implement of the Chinese medicine (hereinafter referred to asCM) internationalization suffers many problems in nowadays, for example theidentity of CM have not been approved, CM is in need of its own standard,protection of the intelligent property right of CM, and most practically technicalbarriers, is the main obstacle. How to solve the technical barriers? It's a hot topicand very important for CM internationalization. From the point of legal measures,both domestic and international law systems should be taken in consideration.This text has totally six parts:The first part takes an overview on the CM internationalization. Firstly, it beginswith the concepts of CM, internationalization and CM internationalization, andnecessities and obstacles of the CM internationalization. Secondly, it goes withcurrent situation and problems faced by CM internationalization. In this context,CM internationalization falls umbrella the botanical drug, which takes a hugpercentage in the CM than other two kinds, namely mineral and of animal. Sobotanical drugs are the core of the CM, and regulations about CM directly in othercountries are all in the name of botanical drugs, like the United Nations and EU.The second part summarizes the technical barriers. The earliest technical barrierproduced in England, was substantially a technical norm for protecting consumers'benefits, then became an unreasonable barrier to the free trade because of thepolitical factors. WTO/TBT specialized restrictions to bring unreasonable technicalspecifications to international economic order, it is a standard for technical norms.The technical barriers aim at the special features and establishment of CM itself,and they are what CM itself has to overcome with, since other nationalgovernments of international top hold tight the weakness of CM to draw up aseries of bars to prevent CM form their local markets.The third part refers to the laws/regulations which have something to do withCM in the United States and EU, both aggressive factors and negative factors tothe strategic implement of the CM internationalization. American FDA (Food andDrug Administration) announced formally in June, 2004 the Guidance forIndustry: The Products of the Botanical Drug, and it will result in huge influenceson the CM internationalization. The EU current 2004/24/EC directive (theProposal for A Directive of the European Parliament and of the Council Amending the Directive) is formally delivered in April 2004 from the EuropeanParliament and the EU council. And what is the influences it will have on the CMinternationalization? In the paper, it is summarized briefly that to the CMinternationalization, the Guidance for Industry: The Products of the BotanicalDrug of the United States with the instruction of EU 2004/24/EC finally madethe biggest law obstacle, namely, identity and standard.Forth part goes deep into the reasons about the issues. The law problem isn't apure legal issue, it has something to do with politics, economy, science technicaland culturaL.etc. The four-part analysis why the laws or regulations in differentnations about the technical standard of CM are so quite different, from four anglesas politics, economy, science technical and cultural background. Therefore, thebest method is to analyze a law problem from the different angles, then putforward the law solution to figure it out..The fifth part is a textual crux. How to solve the problem, namely go throughthe technical barriers and lead the CM to the international market, from the point oflaw, both local law and international law?. Local method's mainly involvesintelligent property right protection and Chinese herbal medicine's standard law,and international law countermeasure system's including bilateral international lawsystem and multilateral system.The last part refers to the conclusion of the research and some items needed togo deeply further. Having known well about the guidance or directive of the USAor the EU, we realize that CM internationalization is and will be suffering fromtough technical trade barrier. Solutions are taken as follows: first of all, CM needsstandard of its own, not west style; second intelligent property right protectionrules and laws should be perfected. Then, on the basis of domestic law of PRC,countermeasure should approach to the international law at the same time, such asbilateral corporation agreement, WTO rules, International Standard Organizationrules, and other multilateral rules. With CM standard and intelligent propertyright of the local laws and other nations, regions(mainly mean the United Statesand the EU in text)reach a bilateral cooperation development agreement, we aresure that we can make the truth of the CM standard internationalization step bystep, and carry out the grand blue print of CM internationalization.