The Italian National Transplant Centre

The National Transplant Centre stems from law n. 91 dated 1st April 1999 as a technical body of the Ministry of Health and, although the establishment of a National Reference Centre was already foreseen by Law n. 644 of 1975, such a body was never implemented.

The Centre is located at the National Institute of Health, institutional place of the technical activities managed by the Ministry of Health. It is chaired by the President of the National Institute of Health (ISS), by the Director-General appointed by the Minister of Health, representatives of inter-regional or regional centers designated by the State-Regions Conference. It is a network that foster the participation of the representatives of those who actually work in the transplantation field, chosen through an authoritative indication of the regional national institutions that are those who actually organize and deliver the health care services within the public system.

Within the reorganization of the transplant system in Italy, the establishment of the National Centre was undoubtedly one of the most important innovations introduced by n.91 dated 1st April 1999. CNT was entrusted with the national coordination of the activity of donation, procurement and transplantation of organs, tissues and cells.

In particular:

  • monitoring of donations, transplants and waiting lists through the information system;
  • the definition of guidelines and operational protocols;
  • the allocation of organs for urgent cases referred to the national catchment area;
  • the definition of the parameters for the auditing of the quality and the outcome of the structures for transplantation;
  • the promotion and coordination of relations with foreign institutions in the field.

To these pivotal tasks, the law adds the collaboration to the promotion of information on the activities of collection, donation and transplant of organs tissues and cells, the management of the IT system and, more generally, an effective role in the functions of organization and management of the transplant system.

The role of the CNT in the framework of transplantation of hematopoietic stem cells is defined for the first time within the State-Regions Agreement n.1770 of 2003 and within the Legislative Decree 191/2007 and within Legislative Decree 16/2010, as transposition of the European Directives 23/2004 and 17 and 86/2006. The coordination is carried out by the CNT in close cooperation, with regard to the clinical part, with the GITMO (Italian Group for Bone Marrow Transplantation), a scientific reference for this type of transplant, for the donation of ESC with National Blood Transplant Center, and for the part relating to the search for unrelated donors, with the Italian Registry of Bone Marrow (IBMDR).

How this role was played in relation to the activities carried out by interregional centers (AIRT, NIT, OCST) and regional centres already operating in the area?

First, as a determining factor for building an efficient network that has been able to connect the existing operational organizations, in order to give cohesion, transparency and exchange of information between coordination centers and transplantation centers; secondly as an organizer of the activities as well as a reference point for ensuring to patients on the waiting list equal access to treatment care they need; finally, as the governing body that can stimulate the system towards greater efficiency and effectiveness of all the activities.

The results achieved in recent years witnessed a steady growth of the system that places our country in a position of prestige within the international arena. However, the particular socio-economic context that the country is going through, imposes an additional reorganization and rationalization of the network, more focused on the needs and expectations of patients, taking into account the economic context. Therefore a process of reorganization and optimization of the system was initiated in which the CNT itself is an operating partner at the national level, interfacing directly with CRTs that are in charge of donors and ensuring h/24 the necessary support for the operative management of national programs.

It is thus removed an operating intermediate passage represented by the three CIR (AIRT, NITp, OCST) that substantially carry out functions of allocation of exceeding of organ and management of national programs previously delegated to them by National Transplant Center and whose role appears today anachronistic compared to the evolution of the network, as well as additional cost centers since that with the revision of Title V of the Constitution the regions are entrusted not only with the organization of services, but also with the legislation in order to implement them. At that time, the choice to delegate to the CIR some of the functions attributed to the National Center, was widely shared by the entire network for several reasons: the first one undoubtedly due to the respect for the history of each inter-aggregation that was formed through complex agreements signed between different aggregated regions; the second one due to the fact that the interregional centers already had a nucleus and a core operating structure able of managing supra regional programs and, last not least, the fact that at that time at the CNT there were not the logistical conditions, structural as well as personnel with the necessary know-how to activate a national operating nucleus.

Today, the network has changed considerably and most of the impediments have been overcome. Therefore there are then the conditions for the CNT to take upon itself not only those functions established by the constituting law, but also all transplant programs at national and international level that have been activated over the years. The centralized management of allocations together with the centralized management of the lists, undoubtedly has advantages:

  • The path of allocation through the standardization of processes is made more flowing.
  • It provides an unambiguous interpretation of the rules currently governing such programs and therefore their application is made more effective.
  • It has an interlocutory capacity and a degree of authority certainly higher than those previously held by individual CIR and more and more important as the higher activity managed.
  • It allows a real-time control of donations, allocation flows and the outcome of allocation processes.

So if we look at the reorganization from the point of view of rationalization, we should take into account need and usefulness brought by the rearrangement.