Italian reform of clinical trial rules out of the starting blocks

Marco de Morpurgo

Today, Italian Law 3/2018 – mandating the governement to reform the Italian clinical trial rules – entered into force.  The Italian government now has 12 months to revise the regulatory framework applicable to clinical trials conducted in the country.  The legislative mandate to the government includes an alignment of the Italian clinical trial rules with the EU Clinical Trials Regulation, a drastic reduction of the number of territorial ethics committees along with the creation of a National Co-ordination Centre for ethics committees within the Italian Medicines Agency (AIFA), and a simplification of the administrative formalities regarding the submission of clinical trial applications and requests for ethics committee opinions, among other things.

The new law also requires the government to revise the current Ministerial Decree 17 December 2004 on non-commercial trials in order to allow sponsors to transfer study data to pharmaceutical companies and to allow that such data be used for commercial purposes – including for obtaining a marketing authorisation for a medicinal product.  This is an important novelty given the previous limitations established by the 2004 decree, which prevented pharmaceutical companies from acquiring ex ante contractual rights to study data.  This had triggered an informal practice whereby companies would fund non-commercial trials with a view to acquire study data ex post.  This practice was generally tolerated by AIFA but left companies in a climate of uncertainty that hindered effective and socially useful R&D.

In this article, I discuss the key changes mandated by the new Law 3/2018.  I also outline the new compassionate use regime introduced by Ministerial Decree 7 September 2017, which entered into force in December 2017, insofar as it concerns investigational medicinal products.

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