Italy enters the new system. Minister Schillaci signs four decrees – breaking latest news

Participate in one experimentation it is an opportunity for those who have a serious disease and are unable to obtain benefits with all the already approved therapies available. An opportunity that Italian patients risked losing for bureaucratic reasons. Until today, in fact, Italy had not yet adapted to the well-issued European Regulation nine years ago and, if it hadn’t been done in extremis, we would have missed the train: European patients (and researchers) would have been cut off. After long delays, however, we made it: thanks to the four decrees signed by the Minister of Health Horace Schillaci on January 30, 2023, our country finally adapted to EU legislation.

40,000 Italians participate in an experiment every year

There are around 40,000 Italian citizens who every year, by participating in clinical trials, can benefit from innovative treatments well in advance, even years, compared to their availability. And, therefore, have a better chance of healing, also obtaining improvements in terms of quality of life. They have different pathologies, in two thirds of the cases tumors, hematological and cardiovascular diseases. For this reason too, the Federation of Oncologists, Cardiologists and Hematologists (Foce) had sounded the alarm several times over the last few years: «We thank Minister Schillaci for having accepted the appeal of the clinicians – he underlined Francesco Cognetti, president of Foce, in a press conference organized this morning —. The scientific community applauds the full implementation in our system of the European Regulation, which will allow Italian research to remain at the top in the world. In 2019, in our country, they were authorized 672 trials516 profit and 156 non-profit: two thirds overall concern neoplasms, haematological and cardiovascular diseases, which among other things produce two thirds of the annual mortality».

A single European portal to have more resources

Il Clinical Trial Information System (CTIS), the single continental portal for trials, was officially entered into force on 31 January 2022. He had established it European regulation 536 of 2014, establishing uniform rules to harmonize the process of evaluation and authorization of a clinical study conducted in several Member States. A real revolution, which aims to attract more resources for research in Europe. In short, we have moved from national management to coordination at a European level. «The signs in the last year were really worrying – said Cognetti -: from January to October 2022, 428 applications to start studies were presented (clinical trial application), of which only 87 involved Italy compared to 142 in France, 132 in Spain and 116 in Germany. In the absence of regulatory compliance, a real halving has been estimated, ie about 300 studies would have been lost compared to 672 in 2019, with serious consequences for patients and for the country. Minister Schillaci’s decrees averted very serious damage to those people 40 thousand Italian patients who find a benefit from early treatment with innovative drugs and strategiesas well as bringing an advantage in the training of professionals of the highest level».

What changes

From today, all trials must be submitted according to the new standards established by European Regulation 536 of 2014, which harmonized the evaluation and authorization process of a clinical study conducted in several Member States. “The Clinical Trial Information System (CTIS) becomes the single access point for the submission, authorization and supervision of clinical trial applications in theEuropean Union (while before each country was on its own, with a waste of time and energy and inevitable bureaucratic delays) – he explained Guido Rasi, past executive director of the European Medicines Agency (EMA) and full professor of Microbiology at the University of Tor Vergata in Rome —. Until now, sponsors had to submit applications separately to the relevant national authorities and ethics committees of each country to obtain regulatory approval. An identical regulatory framework in each Member State ensures that clinical trials are conducted in one unique method, with defined and certain timing. Furthermore, makes patient enrollment easier and faster and the closure of the studies. Again to simplify and shorten the times (even more precious for patients in an advanced stage, who hope for a new experimental treatment as they no longer have other effective options) Italy has adapted reducing the territorial ethics committees to 40 (there were over 90), guaranteeing the independence of the studios and the absence of conflicts of interest. “Italy risked losing the new train of clinical research – added Rasi -. Now we can once again attract investments in this sector, continuing to collaborate with large international centers. Italian scientific works are among the most cited in the world».

The economic value of research

Clinical research has a decisive weight not only on the lives of patients, but also on the “country system” since the total public and private investments
in this sector they are equivalent to over 750 million euros per year, of which 92% comes from funding from pharmaceutical companies for profit studies. Not to mention the “non-profit” or so-called independent studies, i.e. studies not promoted directly by the pharmaceutical industry but by public or non-profit research bodies, which are in decline (-4% in 5 years) and for which the public funding has always been insufficient. “The development of new drugs determines social utility, lengthening the average life of citizens and constitutes a quality investment in the long term – he recalled Giorgio Palù, president of the Italian Medicines Agency (Aifa) —. Clinical research is an engine of economic and social development which can offer an important contribution, thanks to the potential of public-private partnerships. One of the crucial points for the adaptation to Community legislation, achieved with the ministerial decree, was the reduction of the territorial ethics committees from 90 to 40, in addition to the 3 of national value, also thanks to the virtuous synergy developed between the Ministry, Aifa and the Regions . All of this translates into acceleration of decisions and less bureaucratic constraints. The Minister’s decree which regulates the transitional phase relating to the evaluation activities and the methods of interaction between the coordination centre, the territorial ethics committees, those of national value and AIFA is also fundamental”.

Savings for the National Health Service

«Finally from today the scenario is changing and we are entering the new model – he commented Paolo Corradini, president of the Italian Society of Hematology (SIE) —. Clinical research is an engine of economic and social development and the centers where clinical trials are carried out guarantee the growth of the researchers involved. Our country has always been at the highest levels in Europe and to continue doing so, in addition to these decrees, investments and qualified personnel are needed (such as research coordinators and nurses, and data managers). The savings represented by the costs and benefits for the National Health Service for experimental drugs and the services entirely borne by the sponsor companies must also be considered. A potential saving of approximately 400 million euros each year has been estimated, in the area of ​​oncohematology alone, and therefore estimated at a few billion for the whole system. Not only. The positive effect on employment must also be considered, with the use of highly specialized personnel and, therefore, the related industries and the positive economic effects for service providers, with an added value of 2-2.5 euros per every euro invested in clinical trials. «With a view to administrative simplification, the determination of the single fee for clinical studies, long overdue – he recalled Saverio Cinieri, president of the Italian Association of Medical Oncology (Aiom) —. After these important decisions, we hope that scientific research will become a priority on the government agenda. We ask for more resources: despite having few available, the studies conducted in Italy have changed clinical practice internationally in different types of tumors, leading to the modification of guidelines and recommendations. In 2022, 390,700 new cancer diagnoses were estimated in Italy, with an increase of over 14,000 cases in two years: research and prevention must be the cornerstones of the commitment of clinicians and institutions against neoplasms”. “We are facing a revision of the entire research system in Italy – he concluded Pasquale Perrone Filardi, president of the Italian Society of Cardiology (Sic) —. On the one hand, the reduction of territorial ethics committees, on the other, the identification of methods to protect the independence of the firms and guarantee the absence of conflicts of interest. Indeed, the European Regulation requires that the persons in charge of validating and evaluating the application have no conflicts of interest, are independent of the promoter, the clinical trial site and the investigators involved as well as the lenders, and are free from any undue influence. In this sense, one of the ministerial decrees harmonises the legislation governing, in particular, the functions of the Ethics Committees and their composition, also in order to guarantee their independence».