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Mandating data exclusivity for pharmaceuticals through international agreements : a fair idea?

Lisa Diependaele (UGent) and Sigrid Sterckx (UGent)
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Abstract
Data exclusivity is temporary exclusive user right on the clinical data that need to be submitted to the regulatory authorities to prove that a new drug is safe and effective. For the pharmaceutical industry, data exclusivity is an important addition to the patent system, as data exclusivity will de facto delay the market entry of generic drugs until after the exclusive user rights on the clinical data have expired. In order to assess the normative legitimacy of the industry’s demand to include minimum standards for data exclusivity in international agreements, this contribution evaluates the three justifications that have frequently been advanced, depicting data exclusivity as (1) an essential policy tool to promote innovation; (2) a mechanism to prevent the generic industry from ‘free-riding’; and (3) a legal instrument to protect the industry’s property rights in clinical data.

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Citation

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Chicago
Diependaele, Lisa, and Sigrid Sterckx. 2018. “Mandating Data Exclusivity for Pharmaceuticals Through International Agreements : a Fair Idea?” In The Palgrave Handbook of Philosophy and Public Policy, ed. David Boonin, 575–591. Cham, Switzerland: Palgrave Macmillan.
APA
Diependaele, L., & Sterckx, S. (2018). Mandating data exclusivity for pharmaceuticals through international agreements : a fair idea? In D. Boonin (Ed.), The Palgrave handbook of philosophy and public policy (pp. 575–591). Cham, Switzerland: Palgrave Macmillan.
Vancouver
1.
Diependaele L, Sterckx S. Mandating data exclusivity for pharmaceuticals through international agreements : a fair idea? In: Boonin D, editor. The Palgrave handbook of philosophy and public policy. Cham, Switzerland: Palgrave Macmillan; 2018. p. 575–91.
MLA
Diependaele, Lisa, and Sigrid Sterckx. “Mandating Data Exclusivity for Pharmaceuticals Through International Agreements : a Fair Idea?” The Palgrave Handbook of Philosophy and Public Policy. Ed. David Boonin. Cham, Switzerland: Palgrave Macmillan, 2018. 575–591. Print.
@incollection{8562150,
  abstract     = {Data exclusivity is temporary exclusive user right on the clinical data that need to be submitted to the regulatory authorities to prove that a new drug is safe and effective. For the pharmaceutical industry, data exclusivity is an important addition to the patent system, as data exclusivity will de facto delay the market entry of generic drugs until after the exclusive user rights on the clinical data have expired. In order to assess the normative legitimacy of the industry{\textquoteright}s demand to include minimum standards for data exclusivity in international agreements, this contribution evaluates the three justifications that have frequently been advanced, depicting data exclusivity as (1) an essential policy tool to promote innovation; (2) a mechanism to prevent the generic industry from {\textquoteleft}free-riding{\textquoteright}; and (3) a legal instrument to protect the industry{\textquoteright}s property rights in clinical data.},
  author       = {Diependaele, Lisa and Sterckx, Sigrid},
  booktitle    = {The Palgrave handbook of philosophy and public policy},
  editor       = {Boonin, David},
  isbn         = {9783319939063},
  language     = {eng},
  pages        = {575--591},
  publisher    = {Palgrave Macmillan},
  title        = {Mandating data exclusivity for pharmaceuticals through international agreements : a fair idea?},
  url          = {http://dx.doi.org/10.1007/978-3-319-93907-0\_44},
  year         = {2018},
}

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