Regarding the conference "Where the patient is hidden. The role of the Ethics Committee between experimentation and bureaucracy"

On Tuesday 5 June, the University Centre for Bioethics of Università Cattolica organised a conference entitled "Where the patient is hidden. The role of the Ethics Committee between experimentation and bureaucracy". In opening the Conference, Prof. Adriano Pessina, Director of the Center, highlighted how, "in the almost total silence of public opinion and places dedicated to clinical and pharmacological research, some legislative interventions have in fact initiated a reform of the Ethics Committees that would deserve a much broader discussion. It should not be forgotten, in fact, that the Ethics Committees are both the filter of pharmacological research, whose economic impact must always be remembered, and the protection of the rights of patients who are in fact the co-protagonists of the experimentation itself." Precisely for this reason, the Conference was not only aimed at specialists in the sector, according to Pessina, in fact: "if the effectiveness and efficiency of an Ethics Committee constitute an essential guarantee of the protection of the health of individuals, the question of the specific preparation of the members of the Ethics Committees and the necessary re-evaluation of their tasks and roles exists and must be seriously posed".

The Conference - coordinated by Prof. Alessio Musio, member of the Scientific Committee of the University Center for Bioethics and of the Ethics Committee of the Niguarda Hospital in Milan - thus outlined a long and articulated debate that involved the speakers.

The reference to the "raison d'être of the Ethics Committee" - formulated in his report by Prof. Antonio G. Spagnolo, Director of the Institute of Bioethics of the Catholic University of Rome - and the clarification of the "rights of the patient in clinical trials according to a constitutional perspective" - conducted by Prof. Giampaolo Azzoni, Director of the Center for General and Applied Ethics, University of Pavia - have been the way to think critically about the new legislative guidelines that have in fact governed and modified the activity of the Ethics Committees in recent years.

In particular, it was Prof. Gianni Tognoni, Director of the Mario Blacks Sud Consortium, who presented, after outlining an overview of the number of Ethics Committees present in Italy compared with other European countries, "a critical analysis of Law no. 27 of 24 March 2012" which in fact changed the competences of the Ethics Committees. In his report, Prof. Tognoni also presented the contents of a document, signed by a wide network of Italian Ethics Committees, aimed at denouncing the possible reduction of the Ethics Committee to a "bureaucratic-clerical" role according to a scheme that risks losing sight of the rights of the patient-citizen. Dr. Marina Ferri's report, "The difficult balance between bureaucracy and patients' rights" tried to show, however, how even in this regulatory framework, there is room, in the face of its extended interpretation, for a broad exercise of the prerogatives of the Ethics Committee, bringing as an example in particular the experience of the Ethics Committee of the ASL of Trento.

It was the turn of Prof. Carlo Hanau, then, President of the Federation of Rare Disease Associations of Emilia Romagna and of the Health Court of Bologna, to examine how "the insurance imposed by the Ministerial Decree of 14 July 2009" has in fact severely limited the possibilities of carrying out spontaneous or truly non-profit experiments such as those concerning rare diseases without for this reason, of economic interest for the large pharmaceutical multinationals.

In the report by Giovanna Oliva, President of the AUS Niguarda Spinal Unit Association and Patient Representative within the Ethics Committee of the Niguarda Hospital in Milan, the patients' point of view emerged with respect to the changes in the role of the Ethics Committees, with a direct position on the quality and effective involvement of patient representatives within the decision-making processes of the Ethics Committee itself.

In his conclusion to the work, Prof. Pessina formulated "the hope that this moment of reflection can increasingly involve those who concretely carry out research in hospitals, in a framework of real collaboration with the Ethics Committees, and can also find the right attention from the Ministry of Health".