21 Reasons Paragraph Six Negotiations Are Becoming A Joke

James Love
February 8, 2003

At a certain point, we have to admit that the para 6 negotiations are becoming a joke. Here are 21 reasons why.

1. Japan asked TRIPS Chair Motta to remove vaccines from the definition of products to be covered. He does. Developing countries and health care groups object, it stays out. Not even one developed economy objects to the removal of vaccines from the text.

2. The EU issues a list of diseases that includes AIDS and mostly commercially unimportant diseases as the main public health problems in developing countries. They ignore cancer (an estimated 80 million suffering without treatment in developing countries, 80 percent of the deaths from cervical cancer in developing countries.), diabetes (two thirds of the 150 million diabetics live in developing countries), asthma (10 to 30 per of children suffer from asthma in several developing countries), or heart disease (78% of deaths linked to cardiovascular diseases occur in low and middle-income countries), and are open about the fact that this exclusion is designed to protect patent owners for drugs that treat those diseases.

3. Lamy, Zoellick and others repeatedly make a distinction between infectious diseases and all other conditions or diseases, as if persons who suffer from a genetic condition or an injury are somehow less worthy of receiving health care than persons who suffer from an infection.

4. Many delegates introduce the "major" test, so if a diseases is not among the leading causes of suffering it should not be treated.

5. Treatments that would relieve severe pain, allow children to breath normally, or treat terrible skin conditions are ridiculed as unimportant, and delegates insist on language to exclude such treatments,

6. Dispute existing regulatory registration safeguards and Article 31 safeguards to protect patent owners in importing countries, the EU insists that poor countries adopt expensive and unprecdedented regulatory, procedural and legal requirements, including direct reporting of individual licenses to the WTO Secretariat, none of which apply to the free movement of goods within the EU, and none of which will apply to the EU community patent.

7. The US, EU, Canada, Japan and Switzerland insist on an annex for qualification that appears to exclude nearly all non-LDCs, including Brazil, currently the most important importer of generic AIDS drugs. Not one developed economy objects to this.

8. Not one developed economy proposes rules that would limit their rights to parallel trade from poor countries. Not one developed economy proposes rules to limit reference pricing mechanisms that point to poor countries (such as the US law that requires the US VA to get the best world price on medicines). All burdens are placed on poor countries.

9. Japan seeks steadily to have more difficult burdens on disease coverage, such as "national emgerency." This is a country that has issued hundreds of compulsory licenses on patents for manufactured goods, to promote its export industries.

10. The Doha Declaration is probably due to the US and Canadian panic over anthrax medications. The US pushed hard to restrict paragraph 6 to only three diseases, AIDS, Malaria and TB, excluding even biological weapons. But in the weeks before the Iraq war, where the US claims biological weapons are going to be the main issue, the US supports exclusion of vaccines, forcing countries to have their own vaccine facilities, supposedly something that increases the risk of biological weapons, or to be powerless even in the face of a biological attack.

11. No countries table information on the treatment of exports under the US and Canada "bolar" exceptions.

12. No counties table information on the treatment of exports under the EU community patent.

13. No countries table information on the language of EU parliament amendment 196.

14. No country tables information on how the US, Japan, and EU use compulsory licensing under competition laws to permit exports, and of course, the WTO Secretariat does not provide information on this.

15. No countries table information on the scope of disease coverage in social insurance programs in rich countries. Double standards are just assumed to be normal.

16. Some developed economies (larger than most developing countries, but small relative to US, EU and Japan), don't protect their own populations. Early this year NZ issues a warning to firms that don't provide adequate supplies, and increasingly, NZ faces problems when firms refuse to supply at prices the government sets (such as the ddI case), but NZ does not ask the WTO to be included in paragraph 6 solution. Outside the WTO context, NZ says that some patients will die in NZ because the government will not cover high priced products for some rare diseases. In these cases, NZ could never justify domestic production, but this is not discussed at the WTO because of US trade pressure.

17. The WTO Secretariat and some WTO members announce they are negotiating directly with Pfizer to find a text acceptable to the US government.

18. The WHO issues a number of documents and statements on the scope of diseases and the Annex issues, all of which are ignored. The US pressures the WHO to stop speaking on this issue. The WHO is not allowed to participate in informal TRIPS council meetings where the scope of disease or the Annex or the safeguards are discussed.

19. As Canada and the UK push for a restrictive paragraph 6 solution, they stuggle internally to override or curb the patent rights of Myriad Technologies on a patent covering diagnostic tests for breast cancer (an excluded technology under paragraph 6). While developing countries are asked to forgo treatments for cancer, Canada, the UK and other Northern governments are seeking to address a patent abuse so their women can find out if they have a greater risk of cancer. The EU issues a compulsory license for a German database of pharmaceutical prices, acting on behalf of European pharmaceutical copmanies who are the consumers of the data. So in Europe, a high price on a database on the prices of medicines is considered worthy of a compulsory license, but Europe does not think the case where medicine is priced out of reach of 80 million poor cancer patients or 100 million poor diabetics patients is a "public health problem," because cancer or diabetes are not infectious diseases. Meanwhile, the EU is implemeting its biotechnology directive, which features mandatory compulsory licensing of genetically modified plant varieties, something that Lamy does not mention in his speeches on the importance of strong IP rights on cancer and diabetes medicines.

20. As the US lectures the world on patent rights, the FTC is investigating a compulsory license for the Unocal clean fuel patent, on behalf of ExxonMobile. The FTC puts enormous pressure on Unocal to license its technology on reasonable terms to ExxonMobile and other oil companies. After all, clean air is a "public health problem" in the US. But of course, we also seek compulsory licenses on software and Internet related technologies.

21. The US and EU support a text that will only allow Africa to create regional agreements on exports. Leaving out Latin America and Asia. This while Europe is rapidly eliminating all export barriers within Europe, which has a special status in the WTO. No developed economy points out the obvious unfairness of this to Latin America or Asia.

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