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reducing their twelve-year data exclusivity protection to seven years in order to reduce costs of the treatment. 78 Biologics were one of the last issues to be resolved in TPP - perhaps the more inter- esting it is that the US did not get their own way. The reason might have been a firm opposition on the topic of biologics from Australia, which was clear that it will not extend the protection period. 79 Australia, for example, offers a data protection period of five years, which applies to all prescription medicines. During this period, a biosimilars producer cannot rely on data submitted by the biologics producer while obtaining marketing approval for the original drug; 80 therefore, the generic manufacturer would have to perform his own tests, which are too lengthy and expensive. Moreover, the approval agency cannot begin to evaluate a biosimilar application during the data protection period; therefore, a follow-on product enters the market at least six years after the originator’s entry. The final version of TPP shows an enormous compromise from the US. While origi- nally proposing the data exclusivity period of twelve years, the signed text provides for minimum of only five years. The TPP signatories can either (1) give an eight years market exclusivity counting from the date the biologic is approved in the country con- cerned or (2) give five years market exclusivity and other measures to deliver a compa- rable market outcome. 81 Some TPP countries have already stated that this provision does not require them to change their national law. 82 For example Japan and Canada now offer eight years of data exclusivity for biologicals. Moreover, the TPP provides a five-year transitional pe- riod for countries to implement the data exclusivity for biologics. 83 As was previously mentioned, even in the US, who were proponents of a much longer data exclusivity, have been tendencies to limit the period to seven years. Such a change will bring about 3 billion USD savings on pharmaceuticals for the federal health programs. VI. Discussion The TRIPS-plus provisions concluded by the US in FTAs clearly go beyond the TRIPS agreement. 84 Whereas the TRIPS aimed to protect access to medicines, the US usually require their trading partners to give up the flexibility offered by the TRIPS. Almost all FTAs concluded by the US include the patent term extension provisions (which compensate the marketing approval delays) or patent linkage. However, most

78 Trading Away Health supra note 151. 79 The Conversation supra note 144. 80 The Conversation supra note 144.

81 Biologics supra note 144. 82 Biologics supra note 144. 83 TPP footnote 61. 84 Jean-Frédéric Morin “Tripping up TRIPs debates: IP and Health in Bilateral Agreements” (2006) 1:1/2 Int J Intellect Property Manag.

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