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It is also intended to provide a patent system that is competitive with other developed nations.
Other statements in the explanatory memorandum explain that 'competitive' is meant in the sense oxycodone hci acetaminophen 5mg of attracting investment in pharmaceutical R&D to Australia. Providing a new pharmaceutical product to the Australian market involves considerable costs. Therefore, pharmaceutical companies require an appropriate return on the outlays associated with gaining regulatory approval and supplying the Australian market. The extension of adderall vs strattera term scheme has been referred to as compensating pharmaceutical companies for the cost and time taken to meet regulatory requirements including clinical trials. provides an analysis demonstrating the stages and cost of developing a new pharmaceutical product including an indicative breakdown of the costs at each stage of the process. Figure 5.1: Pharmaceutical R&D Cost Analysis by Paul et al (2010) 86 While the extension of term scheme compensates companies for the time taken to obtain TGA approval, the regulatory requirements to formalise to some extent what these companies would consider ethically and legally prudent in any case.
Under existing consumer laws, pharmaceutical companies would not expose themselves to risks associated with providing an unsafe or ineffective medicine to the market. Therefore, while no one should doubt the importance and necessity of a robust regulatory system, it would be inaccurate to consider the activities required oxycodone hci acetaminophen 5mg to meet the regulatory requirements of the TGA as a delay which would otherwise not occur. It is reasonable to say, however, that the need to ensure safety and efficacy delays the marketing of a new drug and thus reduces the value of a patent and that government oxycodone hci acetaminophen 5mg regulation of safety and efficacy may add additional costs and delay. Furthermore, extending patent terms in Australia is an imperfect policy tool for encouraging pharmaceutical innovation because of its limited capacity to provide an increased incentive to innovate as described below. As discussed in the 1984 IPAC Report, one shortcoming of such a scheme is that the projected value of an extension at the time of making an investment decision, the net present value (NPV), is relatively small. The additional returns provided by the patent extension have to be discounted for the cost of capital over time and the inherent risk associated with bringing a new pharmaceutical product to market. Value of extensions versus R&D subsidies In table 5.1 below we examine the economics of assisting pharmaceutical R&D with two different mechanisms. The first is a patent extension and the second is a oxycodone hci acetaminophen 5mg government subsidy. Consider two policy means of encouraging investment in Australian pharmaceutical innovation. There are a wide range of possible investments that investors can make, and only some of them will pay off.
Two policy mechanisms are considered for trying to get investors to expand their investment in more marginal projects. The first is expanding patents from 20 to 25 years. We then compare the NPV of future projects with and without a patent extension oxycodone hci acetaminophen 5mg to determine the incremental improvement in the economics of the R&D project brought about by the patent extension. We assume no inflation such that a dollar at the end of the 25 years is worth the same as a dollar at the beginning.
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