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Issue 102 | September 3, 2003
WTO Allows Export of Compulsory
Licensed Pharmaceuticals
 On�August�30 2003, members of the World Trade Organization agreed�to�waive member countries' obligations under Article 31(f) of the Trade-Related Aspects of Intellectual Property Rights ("TRIPS") Agreement requiring�that production under compulsory licensing must be "predominantly for the domestic market."� The Decision of the General Council applies only to pharmaceutical products and is intended�to make it easier for poorer countries to import�pharmaceutical products�made under compulsory licensing if they are unable to manufacture the medicines themselves. U.S., African, and World Health Organization representatives welcomed the deal, while�aid organizations�criticized the plan as flawed, burensome and "doing little to secure future access to medicines in developing countries."���

The Decision follows the November�2001� Declaration on the TRIPS Agreement and Public Health�made in Doha, India where it was agreed that�the TRIPS Agreement�should not prevent members from taking measures to protect public health.� The Doha Declaration�underscored countries' ability to�acheive that end by using certain "flexibilities" that are built into the TRIPS Agreement, including compulsory licensing and parallel importing. Paragraph 6 of the�Declaration specifically instructed the TRIPS Council to find an expeditious solution to the problems faced by members with insufficient�pharmaceutical manufacturing capacity when�making effective use of compulsory licensing. Deadlock over how to resolve this issue effectively�prevented countries that cannot make pharmaceutical products from importing cheaper generics from countries with compulsory licensing.��

The waiver�covers patented products and�products that are made using patented processes in the pharmaceutical sector, including active ingredients and diagnostic kits.� It is intended�to address the public health problems recognized in first paragraph of the Doha Declaration, which says that WTO ministers "recognize the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics."

Although all WTO member countries are eligible,�the following members have agreed to opt out of using the system as importers: Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom and United States of America. The following�members have agreed that they would only use the system as importers in situations of national emergency or other circumstances of extreme urgency: Hong Kong China, Israel, Korea, Kuwait, Macao China, Mexico, Qatar, Singapore, Chinese Taipei, Turkey, United Arab Emirates.� The following members have agreed that they would only use the system as importers in situations of national emergency, and only until their�accession to the European Union:��Czech Republic, Cyprus, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovak Republic, and Slovenia.

The Decision of 30 August 2003 on Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health is available at http://www.wto.org/english/tratop_e
/trips_e/implem_para6_e.htm
�with additional background at http://www.wto.org/english/news_e/pres03_e/pr350_e.htm.�

For more information on this topic, please�contact the author, Bill Heinze (billheinze@tkhr.com) at Thomas, Kayden, Horstemeyer & Risley in Atlanta, Georgia USA.

The information contained in this email is provided for informational purposes only and does not represent legal advice. Neither the APLF nor the author intends to create an attorney client relationship by providing this information to you through this message.

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