PHARMACEUTICALS

Tariffs
  • China’s average tariff on pharmaceuticals is currently 7.0 percent.  This will be reduced to 4.7 percent.  Reductions on all but one pharmaceutical product will be completed by January 1, 2003.
Trading Rights and Distribution
  • Prior to its accession, through various means, China restricted the number of companies that had the right to import and export goods as well as the types of goods that these companies could import.  China has agreed, upon its accession, to eliminate any export performance, trade or foreign exchange balancing, and prior experience requirements as criteria for obtaining or maintaining the right to import and export.  Chinese enterprises will also have full trading rights upon accession, subject to certain minimum registered capital requirements. Joint ventures with minority foreign ownership will be granted full trading rights within one year after accession, and joint ventures with majority foreign ownership will be granted full trading rights within two years after accession.  All enterprises, including those in the pharmaceutical industry, will be granted full trading rights within three years after accession (except with regard to a limited number of products reserved for state trading enterprises, as identified in Annex 2A to the Protocol).
  • For enterprises and individuals that are not invested in China, the right to import and export will be granted in a non-discriminatory and non-discretionary way.  Any requirements will be for customs and fiscal purposes only.  
  • Prior to its accession, China did not generally permit foreign companies to distribute products through wholesale and retail systems in China or to provide related distribution services, such as repair and maintenance services.  These prohibitions will be eliminated three years after accession for pharmaceuticals.  (See sector report on Distribution Services)
Import Procedures
  • China has agreed to bring both its automatic and non-automatic import licensing systems into conformity with the WTO Agreement on Import Licensing, ensuring that these systems will not function as trade barriers and will comply with the principles of national treatment and nondiscrimination. 
  • China will no longer condition importation or investment approvals on whether competing domestic suppliers exist or on performance requirements of any kind, such as export performance, local content, technology transfer, offsets, foreign exchange balancing, or research and development.
Intellectual Property Rights
  • In accordance with the WTO agreement on Trade-Related Intellectual Property Rights (TRIPs), China is obligated to comply with internationally accepted norms for protecting and enforcing the intellectual property rights of U.S. and other foreign companies and individuals in China.
  • China is in the process of modifying its intellectual property laws and regulations, including those relating to patents, trademarks, trade secrets, test data and copyrights.  In addition, China has committed to strengthen the enforcement of these laws and regulations by its courts and the responsible administrative agencies.
  • China has agreed to protect undisclosed test or other data submitted to its authorities to obtain marketing approval of pharmaceuticals and agricultural chemical products so as to ensure that no person can rely on previously submitted data, without the permission of the submitter, for at least six years from the date on which China grants marketing approval to the person submitting the data.  Any second applicant for market authorization will be granted such authorization only if he submits his own data.  The protection of such data will be available to all pharmaceutical and agricultural chemical products that use new chemical entities whether or not they are patent-protected.
  • China has further agreed that it will only impose, apply or enforce laws, regulations or other measures relating to the transfer of technology that are consistent with with the WTO agreement on Trade-Related Investment Measures (TRIMs) and the TRIPs agreement.
Price Controls
  • Within one year after accession, China has committed to provide national treatment with respect to regulations, notices, and measures relating to procedures and formulas for the pricing and classification of imported pharmaceuticals or measures that set limits on profit margins attainable or that create any other conditions regarding price or local content.
  • China has agreed not to use price controls to afford protection to the domestic pharmaceutical industry, and China has agreed that its application of price controls will not have the effect of limiting or otherwise impairing China’s market access commitments.
  • A comprehensive list of those pharmaceuticals that are subject to price controls is set out in Annex 4 to the Protocol.  Price controls will not be extended to additional goods and services except in exceptional circumstances and must be notified to the WTO and published.
Taxes
  • China has agreed to ensure that its laws, regulations, and other measures relating to internal taxes and charges levied on imports comply with WTO rules and are applied uniformly to both foreign and domestic enterprises.  This obligation applies not only to national taxes but to provincial and local taxes as well.
Subsidies
  • China has agreed to eliminate all subsidies on industrial goods that are prohibited under WTO rules, i.e., export and import substitution subsidies.  (See separate report on Import Related Issues)

December 2001
Department of Commerce
International Trade Administration
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