13 June

HEALTHCARE

Clinical trials: the decree implementing the Lorenzin Law is in the OJ

13/06/2019

On 12 June 2019, the new decree on clinical trials for medicinal products for human use (Leg. Decree 52/2019) was published in the Official Journal. In implementing the provisions of Art. 1 of Law 3/2018 (the so called "Lorenzin Law") "delegating powers to the government with regard to clinical trials for medicinal products and provisions for the reorganisation of health professions and the healthcare managers of the Ministry of Health", the new decree impacts current legislation on clinical trials (Leg. Decree 200/2007 and Leg. Decree no. 211/2003). Among the main changes made by Legislative Decree 52/2019, it is noted that Art. 1, "in order to enhance non-profit clinical trials with a low level of intervention" introduces the possibility of transferring the relative data and results for registering purposes, with the obligation of the sponsor to sustain and reimburse direct and indirect trial-related expenses, as well as the relative tariffs if the trial is requalified as a for-profit activity, inclusive of potential revenue deriving from the enhancement of intellectual property. The issuance of a specific decree of the Ministry of Health is foreseen, which provides for a discount scheme for good clinical practice inspections on phase I studies, and the competence for sanctions is transferred from the Ministry of Health to AIFA, as the Authority competent in the field of clinical trials for medicinal products. Article 2, which amends Leg. Decree 211/2003, provides for a single national form for the purpose of submitting an application for the opinion to the Ethics Committee, and requires AIFA to publish the list of facilities authorised to conduct clinical trials. Chapter II of the decree contains provisions for coordination with Reg. 536/2014 on trials, and, in addition to referencing the definitions contained therein, establishes that the Ministry of Health, by means of a decree, adapts the governance on the suitability of facilities at which the clinical trial is conducted to the provisions of the European Regulation, and that within 90 days from the issuance of this decree, AIFA identifies the requirements for the authorisation of centres to conduct trials from phase I to phase IV. The Ministry of Health must also identify the criteria and guidelines for the authorisation of centres for clinical trials of advanced therapies, and AIFA, having consulted the National Coordination Centre of Ethics Committees, will have the task of identifying suitable methods to protect the independence of clinical trials and ensure the absence of conflicts of interest. In this regard, it is envisaged that, in order to guarantee neutrality and impartiality, the subjects appointed with the validation and subsequent evaluation of the application for authorisation of a clinical trial make a declaration as to the absence of conflicts of interest, and that the Ministry of health, subject to agreement in the State-Regions Conference, orders the suppression of any territorial Ethics Committees that violate the terms and procedures on the evaluation of clinical trials or the rules on transparency and on the absence of conflicts of interest. Lastly, two ministerial decrees must, respectively, redefine the procedures for evaluating and authorising clinical trials, and identify the general criteria on the basis of which universities can initiate master's degrees on the methodology of clinical research and trials (Leg. Decree no. 52 of 14 May 2019, published in Official Journal no. 136 of 12 June 2019).