February 9, 2019

Italian government approves a draft legislative decree amending italian legislation on clinical trials

On February 14, 2019, the Italian Government approved a draft legislative decree, implementing Law no. 3/2018 which delegated the Government to take measures to reform the Italian legislation on clinical trials on medicinal products for human use, with the purpose, among other things, to prepare the Italian legal framework to the future application of the Clinical Trial Regulation (EU) 536/2014.

In particular, the draft legislative decree is intended to amend Italian Legislative Decree no. 200/2007 on clinical trials, according to the principles and the guidelines provided for by Law no. 3/2018. On the basis of a non-official version of the draft legislative decree available online, this decree:

(i) introduces the reference to the gender and age medicine among the criteria for the conduction of phase I clinical trials;

(ii) provides for the update of the tariffs of the services provided by the Italian Medicines Agency reported in the Ministerial Decree of December 6, 2016, by means of a future ministerial decree, to be issued within October 30, 2019;

(iii) provides for a simplification of the procedures for using residual biological materials from previous diagnostic or therapeutic activities for clinical research purposes, by means of future guidelines to be issued by the National Health Institute (Istituto Superiore di Sanità);

(iv) provides for the use of specific professionals in charge of the data management of the clinical trial (in compliance with the Regulation (EU) 2017/679 on data protection) and the research coordination;

(v) allows a wider use for commercial purposes of the results of observational clinical studies and non-profit clinical trials, provided that certain conditions are met, including, in particular, the introduction for the sponsor, which intends to benefit from the clinical trial results, of the obligation to reimburse direct and indirect costs related to the trial, as well as any lost revenue resulting from the qualification of the same study as a non-profit activity, including potential income related to the exploitation of intellectual property rights; and

(vi) provides that a decree to be issued by the Minister of Health within October 30, 2019: (a) shall update the Ministerial Decree of December 17, 2004 on non-profit clinical trials; (b) shall identify methods of coordination between public and private sponsors in the context of the same clinical trial or clinical study, also in order to acquire information following the placing on the market of medicines; (c) shall establish criteria to identify non-profit clinical trials and clinical trials conducted with collaboration between public and private sponsors; and (d) shall set out procedures for the transfer of data relating to the clinical trial to the sponsor and their use for medicines registration purposes.

Considering the above, this draft legislative decree does not directly introduce significant news in the legislative framework on the performance of clinical trials on medicines for human use, since it mostly provides for further ministerial decrees or guidelines to be issued by the Ministry of Health or other public entities, such as the National Health Institute, to regulate the relevant matters.

In addition, such legislative decree is still in a draft form, since it has received a preliminary approval from the Italian Government on February 14, 2019  but it still has to be submitted to the Italian Parliament to get the opinions by the competent parliamentary committees, as required by Law no. 3/2018. These opinions should be issued within the following 45 days; if such opinions will not be provided within the given term, the draft legislative decree may be finally issued and published in the Italian Official Journal.

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