26 February 2003 The Hon Mark Vaile MP Minister for Trade Parliament House CANBERRA ACT 2600 Dear Minister: TRIPS NEGOTIATIONS ON PHARMACEUTICALS I would like to thank you for your most prompt replies to our recent letters on the effects of bilateral trade on the PBS, and on the progress of talks in Geneva on the access by developing countries to affordable medicines under the TRIPS measures. In your letter on the second matter, you looked forward to the ACA and Consumers International playing a constructive role in finding a balanced solution to the matters arising from the Doha round. This letter is written with such a constructive and balanced approach in mind. As you know, negotiations in Geneva to formalise the supply of affordable medicines to developing and least-developed countries under the TRIPS arrangements broke down on 24 December. In terms of its potential for saving life and reducing suffering, this is one of the most crucial initiatives in international trade for many years, and it is essential that the talks should resume and be successfully concluded. As your Departmentís background document on this issue notes, resolution of this issue was prevented by just one country, the United States. The US Trade Representativesí policy of limiting the scope of an agreement under TRIPS to a narrow range of diseases is clearly unacceptable to a number of poorer countries. At the same time, there must be reasonable protection for the intellectual property rights of originator companies and, above all, the potential for cheap generic versions of patented medicines to flow back into developed-country markets must be addressed. We believe Australia is well placed to play a significant role in bringing the two sides together and advocating proposals that will solve the impasse. If our trade officials can do this, the world will owe them a substantial debt. With that in mind, we would like to put to you a six- point proposal aimed at resolving this issue. We believe the issue needs to be taken beyond the December 16 text. Briefly, the points are these: ∑ Authorisation for exports under strict conditions. This proposal uses the text recently adopted by the European Parliament as Amendment 196 to its Medicines Act. All countries qualify. ∑ A process for exclusions for inappropriate products. This would be done in two ways: (a) a presumptive set of exclusions, and (b) a process whereby an importing country can be required to provide expert evidence that the imports address a bona fide public health problem in the importing country. ∑ An agreement that developed economies would not undertake parallel trade in medicines and health technology products from developing countries to developed-country markets. ∑ An agreement that developed economies would not use reference pricing systems that were based on prices in developing countries. ∑ A technology transfer proposal. Developed economies would be required to provide non-exclusive licenses to developing countries for patent rights funded or owned by the government of the developed country. I enclose our proposal for your consideration. Yours sincerely LOUISE SYLVAN Chief Executive Officer Australian Consumersí Association 57 Carrington Street MARRICKVILLE NSW 2204
TOWARDS A SOLUTION A PROPOSAL TO RESOLVE THE IMPASSE IN THE TRIPS NEGOTIATIONS ON PHARMACEUTICALS AND HEALTH TECHNOLOGY PRODUCTS 1. Exports to countries where manufacturing is not economically viable Members may permit non-patent holders to manufacture and export a pharmaceutical or health technology product which is protected by one or more patents, if the product is intended for export to a third country that has issued a compulsory licensing for that product, or where a patent is not in force, and if there is a request for exports by the competent public health authorities of that third country. 2. Exclusions from export authorization (i) Presumptively excluded from the export exception in paragraph 1 will be any product for treatment of the following conditions: (a) Weight loss, or weight gain, except for conditions relating to another health care problem, such as weight loss associated with AIDS; (b) Fertility; (c) Cosmetic purposes or hair growth; (d) Erectile dysfunction. (ii) For any product not presumptively excluded from the export exception in paragraph 1, a member which believes the product will not be used to meet a public health need may file an objection with the TRIPS Council. In such instance, the importing Member must convene a panel of public health experts to review the matter within 30 days. Submission to the TRIPS Council of a finding by such a panel that the imports will meet a public health need will constitute conclusive evidence and shall be sufficient to authorize the export. 3. Limits on parallel trade from developing countries to developed countries WTO members agree that pharmaceutical or health technology products imported into a developing or least-developed country under this system, whether manufactured and marketed by the patent holder or not, should not subsequently be re- imported into a developed country. This measure should be implemented by import bans in developed countries, rather than by export bans in developing and least-developed countries. WTO members agree to review the necessary amendments to the TRIPS or other WTO agreements, and to enact this agreement at the WTO Ministerial meeting in Cancun. 4. Developed countries not to set prices with reference to developing country prices Developed country members shall agree not to use prices in developing or least developed countries as part of reference pricing arrangements for pharmaceuticals or health technology products. Thus, price discounts made available in developing or least developed countries shall not affect price structures determined by reference pricing in developed countries. (NB: Reference pricing is the practice of setting prices by reference to prices available in other jurisdictions. Reference pricing is used by many governments either for national price controls or to establish price ranges or caps for government purchases, particularly of pharmaceuticals. Governments would be free to use other methods of price controls, including systems reference pricing in developed economies, or that use other methods of setting maximum prices). 5. Facilitation of technology transfer Developed country members agree to grant non-exclusive licenses to all developing or least developed countries for use in developing or least developed countries of all pharmaceuticals or health technology products for which the developed country members hold patent or other intellectual property rights.
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