The EFRETOS project (European Framework for the Evaluation of Organ Transplants)
Efretos was completed in 2011. In line with the European Commission’s 2009-2015 action plan, its primary objective was to identify the conditions required to implement a European post-transplant follow-up patient register that would also be used to facilitate studies of rare pathologies for which national data is insufficient. Efretos together with the European Society of Transplantation brought together international experts who defined the data to be collected by the register and crucially, identified data quality requirements.
The project also dealt with other issues related to directive 2010/53/EU on standards of quality and safety of human organs in Europe. One working party focused on European practices concerning the use of organs collected from “extended criteria donors” (i.e. donors suffering from intoxication, a tumour (cured or not), positive serology for hepatitis B and C, risk factors for viral infectious diseases, or an emerging infectious disease). Their conclusions led the inclusion of data items in the European register to evaluate the consequences of transplanting organs from this type of donor.
Finally, consistent with the directive’s emphasis on the quality of organs transplanted and the safety of recipients, a detailed review was carried out of organ vigilance systems in various European countries and the United States. On the basis of these elements, and following extensive debate, particularly with regard to feasibility and efficiency, recommendations were made for the organisation of an organ vigilance system on a European scale.
The results were presented during the final project meeting which brought together European transplant professionals, institutional representatives, health care service providers and representatives of the European Commission. The project partners’ detailed recommendations, in particular the content and organisation of the registe, were presented, targeting primarily the European Commission.
The SOHO V&S project (Substances Of Human Origin, Vigilance & Surveillance)
Soho V&S is a three year project that started in March 2010. Its principle objective is to define common vigilance procedures for the declaration, investigation and management of serious adverse events and reactions in tissues and cells. The Italian National Transplantation Centre (CNT) coordinates the project which brings together ten partners including eight competent authorities from six member states (Spain, Ireland, Italy, the United Kingdom and France) as well as the World Health Organisation and the Donor Action foundation.
The work of the project is structured around six themes : a survey of the European Vigilance systems ; Vigilance in Assisted Reproductive Technology (ART) ; Illegal activities and fraud ; investigation and management of adverse events and reactions ; training in adverse event management and the promotion of vigilance and surveillance by clinical users.
The Agence de la biomédecine led the work on vigilance in ART. In 2010 it organised meetings of experts and a workshop exploring the current state of ART vigilance systems in Europe and submitted their findings to the European Commission. The project also produced an ART vigilance implementation guide for member state competent authorities that was delivered to the Commission in September 2011.
The COORENOR project (Coordinating an European Initiative among National Organisations for Organ Transplantation) :
Coorenor, which ran from July 2010 to December 2012 set up a coordinated network of national organ transplantation programmes. It brought together 13 partners, including 12 European Union member states, to provide coordinated support for emergent organ transplantation programmes in European countries.
The work led by Agence de la biomédecine investigated operational procedures and critical organisational aspects of organ donation and post-transplant follow up in each member state. The comprehensive results and the understanding of the variations they provided enabled the Agence and the consortium to make informed recommendations on future work.
Other transplant organisation project partners surveyed deceased organ donor procurement and living kidney donor medical practices across the EU and developed best practice guidelines. They also set up an information system enabling organ exchange between member states.
Work will probably continue beyond the end of the project in a joint action aiming to increase organ exchange between member states exploiting the organ exchange information system that Coorenor set up. If joint action is implemented, the Agence will lead the work defining the medical conditions required for such organ exchange.
The ODEQUS project (European Quality System Indicators and Methodology on Organ Donation), Odequs was launched in October 2010. The project aims to define a European level organ donation quality system heart beating, cadaveric death and living donors. Medical, procurement, structural and organisational indicators have been identified. These are now the subject of a collaborative effort to quantify and standardise them. They can then be used to develop a European auditing methodology.
The ACCORD project (Achieving Comprehensive Coordination in Organ Donation throughout the European Union) is a joint action in the field of organ transplantation and donation. The proposal was submitted to DG Sanco in May 2011 and the grant agreement entered into force in Sept 2011. The Spanish national transplantation organisation (ONT) coordinates the project whose overall purpose is to maximise the organ donation and transplantation potential of Member States, to improve cooperation between them and to facilitate the implementation of certain aspects of the 2010/53/EU “organ” directive.
This project involves :
- Collaborative development of national registers to monitor living donors in line with the Organs directive, whilst facilitating data exchange between member states and specifying a European register.
- Optimising the detection of potential deceased donors in intensive care units and all the associated processes.
- Twinning projects between eight countries for the transfer of expertise to countries developing their own transplantation systems.
The Agence de la biomédecine leads the twinning initiative. Specifically it is working with the Bulgarian transplant agency to develop organ transplants and particularly paediatric kidney transplants. Other twinning projects associate the Netherlands with Hungary, Italy with Cyprus, Malta and the Czech Republic.