Drug trials are a necessary step before going to market. Experimental use must be carried on avoiding harm to the environment, safeguarding the wellbeing, life, and health of all who are going to be involved, and with a preliminary and careful cost/benefits analysis. Animal testing is regulated by Dir. 2010/63/EU (implemented in Italy by D. Lgs. 26/2014). According to the increased sensitivity to animals, this law promotes the development of alternative methods that can reduce tests on animals. Clinical trials are going to be regulated soon by Reg. EU 536/2014, which will enter into force in October 2018, repealing the dir. 2001/20/EC (implemented in Italy by D. Lgs. 211/2003). The essay examines the foreseeable consequences of the new rules and indicates some delicate non-harmonized points, such as: the number of the ethic committees and the interplay among them, insurance coverage of profit and no-profit studies, remuneration of participants, the acquisition of informed consent, liability and insurance coverage of damages produced by the trial. The ability of Italy to bridge the gaps is going to be fundamental for being able to carry on drug trials and this is going to influence the development of pharmaceutical research in our Country.

La sperimentazione dei farmaci

G. Savorani
2017

Abstract

Drug trials are a necessary step before going to market. Experimental use must be carried on avoiding harm to the environment, safeguarding the wellbeing, life, and health of all who are going to be involved, and with a preliminary and careful cost/benefits analysis. Animal testing is regulated by Dir. 2010/63/EU (implemented in Italy by D. Lgs. 26/2014). According to the increased sensitivity to animals, this law promotes the development of alternative methods that can reduce tests on animals. Clinical trials are going to be regulated soon by Reg. EU 536/2014, which will enter into force in October 2018, repealing the dir. 2001/20/EC (implemented in Italy by D. Lgs. 211/2003). The essay examines the foreseeable consequences of the new rules and indicates some delicate non-harmonized points, such as: the number of the ethic committees and the interplay among them, insurance coverage of profit and no-profit studies, remuneration of participants, the acquisition of informed consent, liability and insurance coverage of damages produced by the trial. The ability of Italy to bridge the gaps is going to be fundamental for being able to carry on drug trials and this is going to influence the development of pharmaceutical research in our Country.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11567/884688
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