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As Maskus (2003, op. cit.) noted, although overall needs in poor countries are immense, “even though some poor countries have collected their demands for a particular drug in a trade agreement covered by this exception, the scale may still be too low to become attractive to potential suppliers… Since eligible import markets will not be large in very small countries, generic drug manufacturers may not be interested in producing these small quantities and waiting for economies of scale.┬áIt is important to note that, in accordance with paragraph 6 of the Doha Declaration, the system will operate in a scenario where there is only one global supplier of patented medicines and therefore there will be no source available for generic drugs. The application of such a system is necessary when the patent holder refuses to supply a patented drug in a country (whose drug manufacturing capacity is insufficient or non-existent) at a price acceptable to the country concerned or under other conditions acceptable to the country concerned. The basic assumption for the application of the system is therefore a situation in which a) a drug is available and could be sold by the patent holder to the country in need, and b) the patent holder opposes it. The Presidency`s statement adds that the special conditions (as defined in point 2b) of the decision12 apply not only to the drugs formulated, but also to the active substances manufactured and delivered under the system as well as to the finished products made with such active substances. The statement also adds (although there is no evidence) that “members understand that, in general, special packaging and/or specific colourings or shapes should not have a significant effect on drug prices.” In addition, the declaration establishes a monitoring system, including the verification, as the member concerned found, of insufficient or non-existent production capacity in the pharmaceutical sector13. It is also important to note that the system covered in paragraph 6 is based on the assumption that a patent holder is legitimized to prevent access to the products under his control, even if there are compelling humanitarian reasons. This is certainly not in line with the Doha Declaration on the TRIPS and Public Health Agreement (particularly paragraph 4) or the commitments made by States under the International Covenant on Economic Rights, Article 12 (recognizing the “human right of all for the purposes of enjoying the highest possible physical and mental health standards” and the obligation to take steps to achieve this right, including “for … Prevention, treatment and control of epidemics, endemic, …

and other diseases”). The adoption of the decision cannot therefore prevent the use of other means if the holder of the patent or patents in question refuses to provide a necessary drug. Countries should be encouraged to develop disciplines to deal with such refusals under the “essential bodies” doctrine 27 or other approaches to competition and health law. 16. However, Section 168 of the Australian Patent Act and Section 55, paragraph 2 of the New Zealand Patent Act allow exports under an agreement with a foreign country to provide products necessary for the defence of that country.