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POLIS Working Papers - Working paper n. 195

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

January 2012


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.

JEL Classification numbers

I18; L51;

Keywords

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

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Periodico mensile on-line "POLIS Working Papers" - Iscrizione n.591 del 12/05/2006 - Tribunale di Alessandria
ISSN: 2038-7296


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