Paragraph Six Exports

Legislation to Allow for the Export of Pharmaceuticals Produced Under Compulsory License

December 6, 2005. WTO reached a decision to make the Paragraph 6/2003 Decision mechanism permanent modifying the TRIPS agreement and incorporating an Article 31 Bis TRIPS Amendment.
August 30, 2003. Decision of the [WTO] General Council of 30 August 2003. Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health.
- August 28, 2004. The General Council Chairperson’s Statement.
November 20, 2001. WTO Document. Doha Declaration on the TRIPS Agreement and public health.
China - In November, 2005, China passed State Intellectual Propery Office Order 37. This would permit the export of medicines, APIs and diagnostic kits produced under compulsory license for nations that had notified the WTO of their intention to import them. It limits exports to products to fight infectious diseases. Thanks to MSF for providing an unnofficial translation of Order 37.
Canada - On May 14, 2004, Canada passed BILL C-9: An Act to amend the Patent Act and the Food and Drugs Act. The law came into force on May 14, 2005 ceating Canada's Access to Medicines Regime (CAMR). The purpose of the legislation is to allow Canadian manufacturers to export antiretroviral drugs to countries lacking production capacity. Royalties paid to the patent holder vary according to the importing country's Human Development Index. Civil society groups supported the passage of the legislation, yet they also pointed out a number of flaws in the bill, including; it includes a restrictive lists of medicines, it does not automatically include medicines pre-qualified by WHO (including Fixed-Dose Combination antiretrovirals), it imposes hurdles on NGOs in the field attempting to procure Canadian generics, and it includes language against production that is "commercial" in nature.
By December 2006, no medicines had been exported under this framework. Stakeholders are now debating how to fix the system.
- BILL C-9: An Act to amend the Patent Act and the Food and Drugs Act. (The Jean Chrétien Pledge to Africa).
- November 24, 2006. Canada's Access to Medicines Regime. Consultation Paper seeking input on "how the regime can better deliver on Canada's commitment to improve access to less expensive medicines."
- August 18, 2006. Canadian HIV/AIDS Legal Network and Medecins Sans Frontiers. Groups Urge Rapid Review of Canada's Law on Generic Medicines for Export.
- August 10, 2006. Canadian HIV/AIDS Legal Network and Medecins Sans Frontiers. Will It Deliver? Assessing Canada's Pledge to Export Affordable AIDS Drugs.
- July 16, 2004. Letter from USTR to Canadian Minister of International Trade. Memorandum of Understanding.
- Canadain HIV/AIDS Legal Network Page on Bill C-9.
- CPTech Page on Bill C-9.
The Netherlands - On December 21, 2004, the State Gazzette published the following rules, which went into effect on December 23. Policy rules on issuing compulsory licences pursuant to WTO Decision WT/L/540 on the implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health, under section 57, subsection 1 of the Kingdom Act on Patents of 1995.
European Commission -
- Regulation (EC) No 816/2006 of the European Parliament and of the council on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems. This regulation was published on May 17, 2006. It entered into force on June 9, 2006.
- October 29, 2004. Orignally propsed text. Proposal for a Regulation of the European Parliament and of the Council on Compulsory Licensing of Patents Relating to the Manufacture of Pharmaceutical Products for Export to Countries with Public Health Problems.
- EU Press release. Access to medicines: Commission proposes to allow export of generic medicines to poor countries
- UK Patent Office. Consultation on the Proposed Regulation on Compulsory Licensing of Pharmaceutical Patents for Export to Countries with Public Health Problems.
- MSF Documents
  - January 18, 2005. Presentation by Ellen ‘t Hoen to the European Parliament Committee on International Trade.
  - October 29, 2004. Press Release. Statement on European Commission’s proposal for facilitating export of generic medicines to developing countries.
- July 7, 2005. Khalil Elouardighi (ACT-UP Paris) and Lital Hollander (European AIDS Treatment Group). Op-ed in the Economist. Time for Mandelson to face the global AIDS epidemic.
- October 29, 2004. Oxfam press release. EC gives positive signal on access to cheap medicines.
- News Stories
  - November 4, 2004. InPharma.com. EU could allow generics of patented drugs for countries in need.
  - November 4, 2004. Stefania Bianchi for the Inter Press Service. Cheaper Medicines for AIDS Welcomed.
  - October 29, 2004. Associated Press. EU proposes help to poor countries seeking cheap drugs.
India - In 2005, India amended the Patent Law to implement the Paragraph 6 mechanism. For the law and more information visit website on Indian 2005 Patent Reform.
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."
Korea
- Final Korean Legislation to Amend the Korean Patent Act. This is the text of the language that passed on May 31, 2005. It goes into effect on December 1, 2005.
- February, 2005. HeeSeob Nam. Summary of Position Paper Issued by the Korea Intellectual Property Office to the National Assembly.
- November 26, 2004 Draft Bill for Amending Korean Patent Act. Introduced in the National Assembly on by 15 Congressmen.
- September 21, 2004. Earlier draft of legislation, written by HeeSeob Nam.
Switzerland - Implementation of WTO decision on paragraph 6 of Doha: Proposed amendment to Swiss patent law and the comments of the Berne Declaration.
Norway - Section 49 of Norway's Patents Act was Amended by the Act of 19 December 2003 No. 127, Section 49. The following paragraph was added:
"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).
Misc.
- November 22, 2004 Agence France Presse. France to apply WTO generic drug pact by 2005.
- TRIPS and public health: dedicated [WTO] webpage for notifications.

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