Note: A lot of the content on this page is older material from the export debate between the signing of the Doha Declaration and the August 30th Agreement. To jump to this part of the page, click here.
Also included on this page are Examples of Legislation to Allow for Paragraph Six Exports.
|Documents from 2005 Leading Up to the Hong Kong WTO Ministerial in December|
|Important WTO Documents - Actual Rules on Compulsory Licenses and the Export of Goods Produced Under Compulsory License|
|Legislation to Allow for the Export of Pharmaceuticals Produced Under Compulsory License|
Insertion of new section 92A to the Indian Patent Law - Compulsory licence for export of patented pharmaceutical products in certain exceptional circumstances. " After section 92 of the principal Act, the following section shall be inserted, namely:— 92A. (1) Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, provided compulsory licence has been granted by such country or such country has, by notification or otherwise, allowed importation of the patented pharmaceutical products from India. (2) The Controller shall, on receipt of an application in the prescribed manner, grant a compulsory licence solely for manufacture and export of the concerned pharmaceutical product to such country under such terms and conditions as may be specified and published by him. (3) The provisions of sub-sections (1) and (2) shall be without prejudice to the extent to which pharmaceutical products produced under a compulsory licence can be exported under any other provision of this Act. Explanation.—For the purposes of this section, "pharmaceutical products" means any patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address public health problems and shall be inclusive of ingredients necessary for their manufacture and diagnostic kits required for their use."
"A compulsory licence shall be issued mainly with a view to supplying the domestic market. The King may by regulations prescribe rules that deviate from this."New regulations will need to be added for this to take effect. The regulations have not been drafted yet, but the following document from Norway's Ministry of Foreign Affairs makes specific recommendations for their drafting: Consultation – Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (excerpts).
|Page Index for older documents, mainly from the "paragraph 6" debate leading up to the Cancun Ministerial in September 2003|
6. We recognize that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.
Exceptions to Rights Conferred
Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.
|National Positions on TRIPS and Access to Medicines, Post Doha|
|International Governmental Organizations|
We must now make sure that the agreed system is flexibly implemented, so that developing countries can gain access to medicines. This is a moral imperative.
|Academics and Experts|
|Pharmaceutical Industry Position|
Firehead's curse on persons negotiating the paragraph 6 solution. This is a 1.8 meg quicktime file.
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