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

Roberto Ippoliti and Greta Falavigna

POLIS Working Papers from Institute of Public Policy and Public Choice - POLIS

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.

Keywords: Transaction costs; International Review Boards (IRB); Medical researcher; Research subject; Clinical research (search for similar items in EconPapers)
JEL-codes: I18 L51 (search for similar items in EconPapers)
Pages: 26 pages
Date: 2012-01
New Economics Papers: this item is included in nep-hea
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