7. The representative of Brazil said that the informal meeting of 24-25 July 2002 had been helpful and had strengthened Brazil's view that an authoritative interpretation of Article 30 would be the most efficient solution, keeping in mind the decision-making process within the WTO and the implementation of the provision itself. He expressed appreciation of the input offered by the representative of the WHO in the form of papers and recognized that the WHO also subscribed to the opinion that an authoritative interpretation of Article 30 would be the most consistent and expeditious solution from the public health point of view.
8. With respect to scope and coverage, he recognized that a great number of countries were against a narrow interpretation of the product coverage in the solution. While he did not intend that the solution cover all products related to public health, it was important not to limit product coverage, for example, only to medicines. As pointed out by his delegation earlier, the active ingredient in medicines should be considered a key product that should be included in the coverage. Countries that did not have access to the active ingredients would necessarily be those countries with no or limited manufacturing capacity. Diagnostic kits were also important products for public health purposes of prevention and treatment and should be included in the coverage. While he would like to arrive at a formulation that would cover different understandings of the product scope and coverage, he preferred a reference to "public health related products". In any case, the reference had to be to a clear range of products necessary to protect and promote public health objectives. In this context, he expressed the view that some constructive ambiguity in the terminology could be useful.
9. Regarding the scope of diseases, he said that his delegation would not support any limitation of the solution to specific diseases. The reference to specific diseases in paragraph 1 of the Declaration should not be interpreted as limiting the scope of the Declaration or of paragraph 6. The appropriate scope of diseases covered should be a reference to "public health problems" and any reference to HIV/AIDS, tuberculosis and malaria should be taken as non-exhaustive examples.
10. He said that, in principle, his delegation would prefer not to exclude any category of importing Members, although a political decision by a developed country Member not to take advantage of the solution should be respected. As already pointed out earlier, Brazil fully supported the position of the African group that nothing in the Declaration limited the eligible supplying Members to developing or least-developed countries alone. Indeed, he agreed that this would severely limit the efficacy of the solution as not many developing countries had the ability to export. Also the decision by a developed country to "opt out" of the solution could be interpreted in a negative way.
11. Turning to the question of importing countries where the product was not patented, he said that this did not seem to be as controversial and that most Members seemed to be open to the idea that the solution should apply to such countries. Given that patent rules would be inapplicable in such countries, there were no legal restrictions at the national level that would limit the means whereby they got access to pharmaceutical products. Where there was no local manufacturing capacity in such countries, an authoritative interpretation of Article 30 would ensure that the production, sale and export from other countries were made on a legally predictable basis. In this connection he expressed the view that it might be useful to consider the proposal of the European Communities and the United States of notification of the request by the importing country as a way of ensuring legal certainty for the suppliers. Such notification should not, however, be limited only to a developing or least-developed country Member, as suggested by the United States, as any Member could qualify as a potential supplier.
12. With respect to the issue of assessment of insufficient manufacturing capacity, he stressed the point that general horizontal manufacturing capacity in many sectors did not translate into actual manufacturing capacity for specific pharmaceutical products. Therefore, any across-the-board criteria to effectively assess insufficient manufacturing capacities for a country would be extremely difficult. This could result in unnecessary limitations and conditions for the beneficiary countries that might need to make use of the solution. Clarifying the point made by Brazil in the informal session that such an assessment should be made product by product, he said that such an assessment should only be made by the Member concerned and not by other Members of the WTO. He also expressed himself against both the proposals of the United States and Switzerland stressing that to assess eligibility would be burdensome on the TRIPS Council and would make the solution less expeditious. Both proposals would unnecessarily narrow down the scope of potential beneficiary countries and were not in keeping with the wording of paragraph 6 or in the spirit of the Declaration. Brazil appreciated and supported the position of Hungary that the scope of potential beneficiary countries under the solution should not be narrowed down.
