Titlebook: Intellectual Property Rights in Pharmaceutical Test Data; Origins, Globalisati Adam Buick Book 2023 The Editor(s) (if applicable) and The A

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Approaches to the Implementation of the Protection of Submitted Test Data,t, even considering the need to conform to international obligations in free trade agreements .. However, a number of countries have adapted this intellectual property right in a manner that better takes into account their own regulatory context; these adaptations provide lessons on how to better im

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The Impact of Test Data Exclusivity on Measures for the Protection of Public Health,ins that the test data exclusivity laws of many jurisdictions do not provide for the suspension or waiver of the protection of submitted test data; if greater use of the flexibilities in intellectual property law intended to promote public health is to be made in future, test data exclusivity laws m

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he broader global regulatory pattern that has given rise to these intellectual property rights. Third, by analysing data on drug approvals in the US, it provides an empirical insight into the impact of test dat978-3-031-29438-9978-3-031-29436-5

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An Overview of the Protection of Submitted Test Data,justifications for and criticisms of the protection of submitted test data are considered. A number of proposed alternative means of protecting submitted test data are detailed. Finally, a review is provided of the existing literature on the impact of test data exclusivity on access to medicines.

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