From weaker clinical research to counted funds: the reorganisation of the Irccs does not address the real issues

On 27 March 2026 the Council of Ministers approved the Legislative Decree for the reorganisation of the Institutes of Hospitalization and Treatment with Scientific Character (IRCCS). My experience of 45 years of clinical-scientific activity at the IRCCS Nazionale Tumori Regina Elena in Rome, largely in the role of Chief of Medical Oncology and Director of the Department of Medical Oncology, as well as Scientific Director for about eight years, allows me to formulate judgements and opinions on this sector of healthcare and research based on my long experience and also on my particular affection and attachment to these Institutes, whose establishment was a particularly brilliant and strongly positive idea for the Italian patient community.

These are Institutes whose primary objective is to perform the dual function of high-level clinical care and translational and clinical research, the quality of which is monitored through internationally used objective evaluation parameters such as the number of scientific publications, the Impact Factor, the H-index, the number of clinical trials with the role of Coordinator, or with simple participation, and the total number of patients enrolled in clinical trials, as well as the active mobility of patients both nationally and internationally. The Reorganisation Decree deals with a number of collateral issues, but does not address any of the main current problems that, if not resolved, will soon lead to the unravelling of these institutes and their function in the National Health Service. The main points addressed in the Reform are as follows:

- Supporting the work of the Scientific Director through the figure of an Expert Consultant, a sort of Senior Consultant who can support the Director in his work. These are experts, even if already retired, who are assigned a non-negligible fee that must in any case be included in the overall funding already allocated to IRCCSs, without any economic addition by the Ministry. In the event that the Scientific Director is a university professor, Article 5 of Decree Law 200 is also amended, so that the university professor, who may also be a fixed-term professor, will have two different employers, the IRCCS and the university, and will accumulate two salaries, thus greatly exceeding the ceilings already provided for. In this regard, it is important to emphasise that IRCCSs need to have Scientific Directors who are not half-time, since they have a function that requires them to devote all their time to the institute, and without being forced to settle with themselves on a daily basis potential conflicts of interest between the 2 main employers, in addition to those that would provide them with consultations and advice, which must in any case be possible.

- The intention is also to strengthen the role and activities of the Research Networks, which will become recognised Associations with their own legal personality and will also be able to open up to other NHS Hospitals or to the University and public Research Centres of the highest quality, even as Translational Health Research Centres, and will be able to receive direct funding to carry out four-year projects, funding that will in any case always be charged to the same overall budget of the IRCCSs, taking resources away from the individual IRCCSs themselves. Although I conceptually agree with this idea, the previous experience, especially of the Alliance Against Cancer Network set up many years ago by Minister Sirchia, and of which I was Secretary General, with the aim of finalising projects that had as their primary objective the immediate benefit in the results offered to cancer patients, has subsequently developed into the support of basic research initiatives that have not led to the achievement of the objective set at the time, and therefore without any favourable and short-term relapse for the patients themselves. The opening up of access to these networks to various hospitals and universities and other research centres cancels the old legislation that established precise requirements for the access of various facilities to the IRCCS networks. It should also be considered that today there are already regional networks that have a considerable clinical impact and guarantee a direct impact on care, and other networks, such as that of AIFA or ISS that are not connected to the IRCCS Networks.

The IRCCS networks should have a direct impact on translational research activities for the transfer to clinical research aimed directly at patients and a strengthening of clinical trials, which have instead weakened considerably in recent years and place our country only in fourth place after Spain, Germany and France in terms of the number of clinical trials belonging to the European Platform referred to in EU Regulation No. 536/2014. There has also been a considerable weakening in recent years of non-profit clinical research compared to that sponsored by pharmaceutical companies (17% vs 83% of studies).