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The US and Europe provide additional extensions for paediatric medicines. Under the European Supplementary Protection Certificate (SPC) scheme, an additional six month extension is available where paediatric clinical trial data is required for regulatory approval.
Similarly, in the US an additional six month extension is available for pharmaceuticals in return for performing paediatric studies requested by the FDA. However, it is questionable whether extensions of patent term in Australia are an appropriate, or even sufficient, mechanism for addressing this issue. Firstly, the Australian market is very small in comparison to the larger markets in the US and Europe. Therefore, additional market exclusivity would cardizem cd foradil phentermine evista provide only a very small increase in the level of remuneration for pharmaceutical developers. Secondly, in the case of antibiotics, new treatments are increasingly being held in reserve as a last resort in order to combat the issue of antibiotic resistance. Therefore, digg com health buy tramadol online here additional years of market exclusivity alone are unlikely to provide an adequate incentive for the development of new antibiotics. Moreover, as we have seen earlier in this report, a small extension will have little material impact on the estimated net present value of a potential investment in R&D at the beginning of the inventive process.
With respect to these categories of pharmaceuticals, and also personalised medicines, a more efficient approach would be to provide assistance in the form of additional grant funding or support for clinical trials that would reduce the costs of bringing these drugs to market, rather than relying on extended market monopolies to compensate companies for the cost of bringing drugs to what may only ever be a small market (as discussed in chapter 5).
Technical clarifications and corrections 6.8.1.Section 76A of the Patents Act 22.214.171.124.Current law digg com health buy tramadol online here Section 76A of the Patents how do i inject oxycontin Act provides that for each approved extension of patent term, the patent holder must file a return with Department of Health and Ageing (DoHA). The return must detail the amount hydrocodone overdose mg and origin of any Commonwealth funds spent in the R&D of the drug subject to the extension.
Section 76A of the Patents Act was introduced in 1999 at the same time as the current extension of term provisions. At the time, the government was planning to invest $800 million over ten years to assist the pharmaceutical sector with R&D, with the intention of retaining pharmaceutical research and manufacturing in Australia.131 The extension of term provision digg com health buy tramadol online here was intended as a further measure to encourage investment in R&D in the pharmaceutical industry. The reporting requirements in s.76A were meant to assist the generic link online propecia tramadol digg com health buy tramadol online here government to ioffer com si meridia phentermine evaluate whether extensions of term were in fact achieving this objective.132 In 1998, the Department of Health said that access to the information provided by patentees would be governed by the Freedom of Information Act 1982 but that collective information would be publicly available.133 To its knowledge, the Panel is the first to obtain such collective information.
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