In view of the new European legislation (EU Regulation 536/2014) about the clinical trial, the Law No. 3 of 11 January 2018 (so-called “Legge Lorenzin”) was definitively approved in Italy.
The main purpose of this law is to acquire greater international competitiveness in the field of clinical trials through the following provisions:
- Reorganization and reduction of existing ethics committees.
- Establishment of a National Coordination Center for Ethical Territorial Committees for clinical trials on medicinal products for human use and on medical devices, with the task of coordinating, guiding and monitoring the evaluation activities of ethical aspects related to experimentations.
- Identification, through a subsequent Ministerial Decree, of a maximum number of forty territorial ethics committees (compared to over 100 currently existing), and the recognition of three national ethical committees, one of which reserved for experimentation in the pediatric field.
- Single fee at Italian level.
- More transparency.
- Public and no-profit research valorization.
The first step for implementation of the “Legge Lorenzin” was the institution of the National Coordination Center for Ethical Territorial Committees by Italian Medicines Agency (“AIFA”). Consequently, since the Law allow the Government to issue one or more legislative decrees laying down the minimum content of Clinical Trial Agreements (“CTAs”) covering certain aspects of the conduction of a clinical trial, a public consultation on the two draft CTAs templates (one template for medicinal products and a second one for clinical investigations on medical devices) prepared by the National Coordination Center, has been launched by AIFA in order to collect comments and suggestions for improvements. The consultation of the CTA ended on May 10th, 2019 and now AIFA is evaluating all the suggestions received.
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