This is another article in our 2023 series, “Clinical Trials: A Global Perspective,” which aims to help you understand the complex framework of regulations governing clinical trials, and how those rules may differ between countries and within other jurisdictional boundaries.
Overview
The year 2023 brought major changes in clinical trials and ethics committees.
Four long-awaited decrees on ethics committees were published in the Official Journal on 7 February, representing a decisive step towards the full implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use.
Two of the four decrees mentioned above cover the reorganisation, the technical-organisational aspects and the simplification of the ethics committees network, thereby completing a long process aimed at simplifying trial procedures, improving timing and ultimately increasing Italy's competitiveness in research.
In 2013, a first reform had already reduced the number of ethics committees from 243 to 91, down to today's 90. Subsequently, with Law No. 3/2018, the National Coordination Centre of Ethics Committees was established and vested with the relevant coordination, guidance and monitoring of the committees' activities, to ensure that procedures are standardised and timing is expedited. In 2018, further reform of committees was launched, which is nearing completion with said decrees which, among other things, will bring the number of ethics committees down from 90 to 40, besides the three 3 national ethics committees, bringing us in line with the figures of other major European countries (e.g. France has 40, Germany 53).
The new organisation of ethics committees in Italy
A closer look at these two decrees reveals a three-layered structure of ethics committees.
On the first level, we have three National Ethics Committees: one for Clinical Trials on Advanced Therapies, one for Clinical Trials in the field of Paediatrics, and one for Clinical Trials of Public Research Entities and other National Public Entities ("CENs"). The CENs are exclusively competent in respect of advanced therapies, paediatric clinical trials and trials of public entities, respectively, in relation to trials on drugs, clinical investigations on medical devices and pharmacological observational studies.
The second level comprises the above-mentioned 40 territorial ethics committees ('CETs'). With respect to matters not reserved for the CENs, the CETs will be exclusively responsible for trials on drugs (in cooperation with AIFA), clinical investigations on medical devices and pharmacological observational studies. The CETs will also operate in matters reserved to the CENs, as long as these do not involve the assessment of trials on medicinal products, clinical investigations on medical devices and pharmacological observational studies (e.g. assessing applications for the compassionate use of drugs even if they relate to advanced therapy).
The third level is only optional and consists of local ethics committees, i.e. the 90 ethics committees that currently exist, which branch out into healthcare facilities based on a benchmark distribution of at least one of every million inhabitants ('CELs'). The Regions may choose whether or not to keep the CELs operational. In the first case, the CELs will have residual competence over activities that do not fall within the exclusive competence of the CENs or CETs (e.g. assessment of studies on food products). In any event, the CELs may also carry out duties in matters that fall within the exclusive competence of the CENs and the CETs, provided that these activities do not involve the assessment of trials on medicinal products for human use, clinical investigations on medical devices and observational pharmacological studies (e.g. assessment of applications for compassionate use).
The remaining two decrees, which are a more technical, concern, respectively, the definition of a standard fee for clinical trials and the regulation of the transitional phase.
Next steps
The four decrees are therefore key tools for the correct implementation of the Regulation and for expediting the system. Therefore, as Minister Schillaci declared, we may reasonably expect that "they will improve Italy's performance in the field and head towards less bureaucracy without, however, sacrificing that imperative level of scientific rigour”.
Furthermore, we should add that as of 31 January the CTIS portal, through which trial applications within the EU and the EEA must be filed, became fully operational. The next and final milestone is set for 31 January 2025, the date by which all trials approved under the previous rules will be required to comply with the provisions and obligations of the Regulation and, therefore, will have to be transferred within the CTIS.
On the whole, therefore, we are witnessing the adoption of measures that not only aim to implement the Regulation, but also aim to make Italy more competitive in the field through the simplification of bureaucracy and the enhancement of research and innovation. This is essential to ensure that patients have greater access to innovative healthcare, to attract investment to our country, and to enhance our leading facilities and the great professionalism which is already acknowledged worldwide.
The reorganisation of ethics committees is certainly a significant step in that direction. However, this will not be sufficient without AIFA's full coordination with the new facilities and a general change of pace that proves the system's ability to offer the responsiveness required to make the difference, both in terms of competitiveness and public health.
This is another article in our 2023 series, “Clinical Trials: A Global Perspective,” which aims to help you understand the complex framework of regulations governing clinical trials, and how those rules may differ between countries and within other jurisdictional boundaries. From human subject protection to data integrity to safety reporting requirements, our global team will discuss novel issues arising around the world, including unique Good Clinical Practice, data privacy, decentralization, diversity, expanded access, real-world evidence, and licensing & transactional concerns. In this rapidly evolving arena, new rules may affect all parties involved in the clinical trial & study process, including sponsors, vendors, academic medical centres, and manufacturers of drugs, biological products, and medical devices. Ensure you are subscribed to Hogan Lovells Engage to receive these new insights!
Authored by Giuseppe Aminzade and Angelo Forte.
