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

Author

Listed:
  • 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.

Suggested Citation

  • Ippoliti, Roberto & Falavigna, Greta, 2012. "Pharmaceutical clinical research and regulation: an impact evaluation of public policy," POLIS Working Papers 165, Institute of Public Policy and Public Choice - POLIS.
  • Handle: RePEc:uca:ucapdv:165
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    File URL: http://polis.unipmn.it/pubbl/RePEc/uca/ucapdv/ippoliti195.pdf
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    References listed on IDEAS

    as
    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. 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.
    3. 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.
    Full references (including those not matched with items on IDEAS)

    More about this item

    Keywords

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

    JEL classification:

    • I18 - Health, Education, and Welfare - - Health - - - Government Policy; Regulation; Public Health
    • L51 - Industrial Organization - - Regulation and Industrial Policy - - - Economics of Regulation

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