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2012

Falavigna G., Ippoliti R.

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

Polis working paper

195

Imprese e struttura Industriale

http://polis.unipmn.it/index.php?cosa=ricerca,polis&paper=3175&collana=13

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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