Access to Medicine Versus Test Data Exclusivity: by Owais H. Shaikh PDF

By Owais H. Shaikh

ISBN-10: 2122132132

ISBN-13: 9782122132135

ISBN-10: 2212212232

ISBN-13: 9782212212235

ISBN-10: 3662496542

ISBN-13: 9783662496541

ISBN-10: 3662496550

ISBN-13: 9783662496558

This e-book explores the concept that of try facts exclusivity defense for prescribed drugs. concentrating on paintings 39(3) of the WTO contract on Trade-Related points of highbrow estate Rights (TRIPS contract) and suitable provisions in chosen loose alternate agreements (FTA) and nationwide legislation, it combines normative, ancient, comparative and financial research of try out information exclusivity protection.At the center of this ebook is the unconventional and unique Index of information Exclusivity and entry (IDEAS), which analyzes the effectiveness of try out facts exclusivity provisions in FTAs and nationwide legislation either at the power of exclusivity in addition to on entry to drugs. principles offers a framework for the review of present try out info exclusivity defense criteria at the foundation in their proximity to Article 39(3) of the journeys contract, the scope of exclusivity and the flexibilities in FTAs, and thus in nationwide legislation. This booklet goals to expand nationwide and overseas coverage makers’ clutch of some of the nuances of try out information exclusivity safeguard. moreover, it presents sensible thoughts in regards to designing a suitable felony method with a robust specialise in selling entry to medication for all.

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1159&rep¼rep1& type¼pdf (last visited 2 June 2016) [hereinafter Varian (1998)] and Joseph E. Stiglitz, Knowledge As a Global Public Good in Global Public Goods, 308, (Inge Kaul et al ed. 1999) [hereinafter Stiglitz (1999)]. 7 Varian (1998) at 7 and Stiglitz (1999) at 309–10. 8 Randall G. Holcombe, A Theory of the Theory of Public Goods, 10(1) Rev. Austrian Econ. 1, 1 (1997) [hereinafter Holcombe (1997)]. 9 Bentley & Sherman (2001) at 35. 10 Non-rivalry is an inherent quality of a public good (in the present case, information or knowledge).

Paul, How to improve R&D productivity: the pharmaceutical industry’s grand challenge, 9 Nature Rev. Drug Discovery 203 (2010). pdf (last visited 2 June 2016). 26 Munos (2009) at 962. 27 Id at 966. pdf (last visited 2 June 2016) [hereinafter NIHCM (2002)]. 29 Id at 7. 30 Id at 5. 31 Id at 5–7 and Figure 2. 1 Categories of pharmaceutical products at FDA according to innovativenessa Priority NMEs Standard NMEsb Priority IMDsc Standard IMDsd Other drugs New molecular entity Yes Clinical improvement over existing therapies Yes Level of innovation Most innovative Yes No To No No Yes No No No Least innovative a Table developed as per the information in the NIHCM (2002) at 4 and 7 According to the NIHCM report ‘[t]he FDA rates many NMEs as standard products.

Med. pdf%2Bhtml (last visited 2 June 2016). 2 Trends in Pharmaceutical Innovation 27 substantially improved medicines. In this regard, the following two studies on US Food and Drugs Agency’s new approval data are instructive. 27 In light of the above assertion, test data exclusivity may have a role to play, providing incentive for engaging in imitative research by protecting investment in generation of test data even when the products are not innovative. This is true, where imitative and marginal research is less risky and more profitable than investing in more complex R&D.

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Access to Medicine Versus Test Data Exclusivity: Safeguarding Flexibilities Under International Law by Owais H. Shaikh

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