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Pharmaceutical clinical research and regulation: an impact evaluation of public policy

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  • Ippoliti, Roberto

    ()

  • Falavigna, Greta

    ()

Abstract

Taking human experimentation into account, this work aims at estimating a policy designed to reduce transaction costs that are related to the protection system of patients' rights, with both a normative and positive approach. On the one hand, considering a sample of European countries as counterfactual, an empirical analysis is performed in order to estimate the impact of a national law aimed at harmonizing the procedure to obtain opinions on clinical trials. On the other hand, an alternative law, which might be able to favor the exchange between pharmaceutical companies and patients, is proposed. Assuming that the competitiveness of the national protection system is based on the time required to obtain an authorization for an experimental activity, pharmaceutical clinical research should be positively affected by a reform of the current law. However, there is also evidence of a wasted opportunity to optimize the governance of the national protection system.

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File URL: http://polis.unipmn.it/pubbl/RePEc/uca/ucapdv/ippoliti195.pdf
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Bibliographic Info

Paper provided by Institute of Public Policy and Public Choice - POLIS in its series POLIS Working Papers with number 165.

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Length: 26 pages
Date of creation: Jan 2012
Date of revision:
Handle: RePEc:uca:ucapdv:165

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Web page: http://polis.unipmn.it

Related research

Keywords: Transaction costs; International Review Boards (IRB); Medical researcher; Research subject; Clinical research;

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  1. Coase, R H, 1988. "The Nature of the Firm: Influence," Journal of Law, Economics and Organization, Oxford University Press, vol. 4(1), pages 33-47, Spring.
  2. Cook, Wade D. & Seiford, Larry M., 2009. "Data envelopment analysis (DEA) - Thirty years on," European Journal of Operational Research, Elsevier, vol. 192(1), pages 1-17, January.
  3. Charnes, A. & Cooper, W. W. & Rhodes, E., 1978. "Measuring the efficiency of decision making units," European Journal of Operational Research, Elsevier, vol. 2(6), pages 429-444, November.
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