International Projects

NEWSLETTER TRANSPLANT
The EDQM/Council of Europe publishes Newsletter Transplant 2017, which gives international figures on organ, tissue and cell donation and transplantation. This work is co-ordinated by the Spanish National Transplant Organisation (ONT), which collects and analyses the international data annually through a worldwide network of health authorities and officially-designated individuals (focal points). Download your free copy from https://www.edqm.eu/ or http://www.ont.es/publicaciones/Paginas/Publicaciones.aspx  
EUDONORGAN
Training and social awareness for increasing organ donation in the European Union and neighbouring countries The "Eudonorgan" (Training and social awareness for increasing organ donation in the European Union and neighbouring countries) project started in September 2016. Eudonorgan is coordinated by the University of Barcelona and co-funded by the European Commission. The objective of the three-year project is to increase the donation of organs and tissues through targeted actions in the field of training and communication. Specific ad hoc online and face to face training will be provided, dedicated to healthcare professionals and all donor stakeholders, such as  associations, journalists,  various competent authorities at national and regional level. During the training course, the topic of donation in all its aspects will be taken into account (organs, tissues and hematopoietic stem cells), identifying an integrated and complete communication formula. The project will involve about 400 people from the European Union and neighboring countries. There are two parallel training paths, a first pathway dedicated to staff working in the donation field so that they can train other colleagues and a second path instead  aimed at people who do not work in the donation field, as journalists or patient associations, but may have a positive impact on increasing donation in their country. It is also expected that six events will be held to raise awareness and promote the culture of gift culture in many countries of the European Union. Website: http://eudonorgan.eu/ “Eudonorgan” consortium:
  • University of Barcelona - Bosch i Gimpera Foundation (UB-FBG): coordinator;
  • Donation and Transplantation Institute (DTI)- Barcellona: training;
  • Slovenjia Transplant: dissemination;
  • Croatian Transplant and Biomedicine Center: organization of social events;
  • Italian National Transplant Centre: dissemination;
  • Dinamia Sociedad Cooperativa (Spagna):evaluation.
brochure: Leaflet A5 EUDONORGAN web pagine affiancate
The Effect of Differing Kidney Disease Treatment Modalities and Organ Donation and Transplantation Practices on Health Expenditure and Patient Outcomes (EDITH)
Practices on Health Expenditure and Patient Outcomes (EDITH) Grant agreement PP-1-2016 Pilot project of the European Parliament on chronic kidney disease Chronic kidney diseases (CKD) are the cause of substantial morbidity and mortality and result in a major burden both to the individual patients and society as a whole. There are different treatment options, kidney transplantation being one of them. There is an enormous variability in the overall management of CKD and in the access to transplantation in particular within the European Union (EU) Member States. In order to provide equal access to good quality care, while simultaneously reducing its costs, an alignment of procedures and practices in the treatment of CKD is considered an important goal. In line with EU policies and legislation in the field of chronic diseases and organ transplantation, EDITH aims to assess the different treatment modalities for chronic kidney diseases currently used in the EU and the factors influencing the treatment choices by patients and doctors. In order to achieve the overall objective, the project wants to examine the effect of differing kidney disease treatment modalities and organ donation and transplantation practices on health expenditure and patient outcomes. By supporting the establishment of registries to follow-up living donors as well as transplant recipients, at minima at national levels and in addition also at European level, crucial information to increase the quality and safety of living donors and all transplant recipients will be gathered. This should provide more information on the possibilities of improving donation and transplantation outcomes and rates, thereby improving overall quality of care of patients with CKD. Core work-packages will be devoted to: WP4 - Assessment of different treatment modalities for CKD Preparation of an overview on different treatment modalities for CKD focusing on:  a comparison, from a micro- and macro-economic perspective, of the various treatment modalities for CKD in EU Member States and associated countries (Iceland, Norway, Turkey, Switzerland)  factors that influence the selection of those modalities in Member States and associated countries (Iceland, Norway, Turkey, Switzerland)  factors that influence the treatment choice from the patients’ or doctors’ perceptive  impact of treatment choice on healthcare budgets The Italian National Transplant Centre is co-leader of WP4 together with the Academisch Medisch Centrum on behalf of the European Renal Association – European Dyalisis and Transplant Association (ERA-EDTA) and will be in charge of the evaluation and analysis of impact of costs of different treatment options for CKD. WP5 - Establishment of registries to follow-up living donors WP 5 will support the establishment by EU Member States (MS) of registries to follow-up living kidney donors, in line with Article 15 of Directive 2010/53/EU. This WP will support MS in building up their national systems to follow-up living donors, and for MS interested (and beyond), in the development and implementation of a common, supranational tool to share their data. Such operational tool will be based on the experience learned and recommendations formulated by previous EU-funded projects (e.g. ACCORD Joint Action). WP6 - Establishment of follow-up registers for transplant recipients Establishment of an operational supranational tool (register) to follow-up transplant recipients. The main objective of this work package is therefore to provide for the establishment of a follow up registry of kidney organ transplant recipients in all Member States. Additionally, information on the quality of life of transplant recipients will enable the benefits of transplantation to be more broadly evaluated. Such operational tool will be based on the experience learned and recommendations formulated by previous EU-funded projects (e.g. EFRETOS). Website: www.edith-project.eu Brochure: edith-laymans-brochure
Project TO-066 “Transplantation and Physical Activity”
In the framework of the activities carried out by the CD-P-TO, the Council of Europe Committee on organ donation and Transplantation,  the expert of the Italian National Transplant Centre conducted in 2014 the TO-066 project “Transplantation and Physical Activity”, which had as main topic the evaluation of the present situation among the Council of europe countries about the existence of national project or programs on the quality of life of solid organ transplanted patients focusing on physical activity. A questionnaire has been circulated among the 47 Council of Europe countries and data collected from 18 of these. Results showed that:
  • although follow-up data for transplanted patients are registered and monitored in all the countries surveyed there are no general national rules on how and what to measure apart from standard clinical parameters, blood values, immunosuppression levels, and general health status.
  • Physical activity was found to be recognised as an added value but is not regularly included in most of the programs.
  • Physiotherapy is prescribed by National Health Systems when needed, with some countries providing a few weeks of rehabilitation after liver, heart and lung transplantation.
  • No funding is provided for further physical activity as a means of improving quality of life of transplanted patients.
While the importance of physical activity is widely recognized, the majority of National Health Systems have not yet been able to develop a system for promoting physical activity in general and for transplanted patients in particular. Based on this results a working group composed by the member of the Competent Authorities of Austria, Bulgaria and Slovenia, leaded by the Italian National Transplant Centre and supported by the experts of the Italian protocol “Transplant… and now it’s time for sport” prepared on behalf of the Council of Europe a Position Paper on Transplantation and physical activity. The paper was approved by the Committee of Experts during the 15th CD-P-TO meeting held in Santiago de Compostela in March 2015 and published on the Newsletter Transplant vol.20, 2015. Position paper Brochure
EURO GTP II
The main goal of this 36-moth project is to develop common Good Tissue Practices (Euro-GTP II) for European Tissue Establishments (TE) and Organizations Responsible for Human Application (ORHA), that address the study extent (retrospective, concurrent, prospective and short and long term) needed for human application of the tissues/cells in a safe and effective manner. More specifically:
  • Determining methodologies for assessing the risks associated to novel tissues/cells
  • Determining methodologies for assessing the extent of the studies needed to provide enough quality, safety and efficacy data for the use of tissues/cells
  • Determining the follow up programs, according to the inputs of the previous issues, to ensure safety and support the evaluation of the clinical efficacy
The outputs of this project will provide tools for assessing and verifying the quality, promote safety and assure efficacy of therapies with human tissues, Hematopoietic Stem Cells (HSC) and Assisted Reproductive Technologies (ART), addressing mainly to the implementation of novel T&C preparation processes and clinical indications, but also to the need of retrospective studies where weaknesses or insufficient safety data currently exist. Recommendations will be forwarded to Tissue Establishments (TE) and Organizations Responsible for Human Application (ORHA), as the main actors in the process of validation and designing T&C preparation processes and patient follow-up according to a clinical indication. This project aims to define the threshold of novelty, including definition of the factors that should be considered to determine the scope and depth of the clinical follow-up studies needed. The scope and extent of the recommended studies will be determined on the basis of a risk based approach performed taking into account factors such as the novelty of the product/preparation process/clinical indication, and its technical complexity. A T&C Database of products, preparation procedures, clinical applications and their current status of authorisation and implementation will be established, working as a starting point for determining the ‘novelty’ of processes/therapies by TEs and ORHAs, and allowing the use of established processes/therapies by any centre that strictly follows the same procedure/clinical procedure/indication. This project also aims to define a “GTP’s management model” that could provide impetus for future standards harmonisation and promotion, and allow the establishment of European accreditation and training programs for TE. There are 4 specific Work Packages: WP5 Good Practices for demonstrating safety and quality through recipient follow-up – Generic requirements WP 6 Good Practices for demonstrating safety and quality through recipient follow-up– Tissues WP7 Good Practices for demonstrating safety and quality through recipient follow-up– HSC WP8 Good Practices for demonstrating safety and quality through recipient follow-up – ART WP 9 T&C Database and Interactive assessment tool The project is coordinated by the Spanish Banc De Sang I Teixits (BST) and has started on the 1st of April. CNT is responsible for WP5 and is assisted in its effort by some Italian collaborating partners, namely Fondazione Banca degli Occhi, Banca Multitessuto di Treviso, GITMO e Dipartimento di Fisiopatologia Policlinico Umberto I. www.goodtissuepractices.eu Brochure Newsletter 1_January_EuroGTP II Newsletter 2_July_EuroGTP II_VISTART_ECCTR
VISTART
The 10th October, 2015 started the "VISTART- Vigilance and Inspection for the Safety of Transfusion, Assisted Reproduction and Transplantation" Joint Action, coordinated by the Italian National Transplant Center and the Italian National Blood Centre. The Action, involving 17 National Organizations belonging to 14 EU Member States and 21 National Organizations as partners, is co-financed by the program dedicated to the Health of the European Union. The Joint Action aims at supporting the Member States of the European Union to improve and implement quality and safety requirements set out in European Directives over the years, in the blood , tissues and reproductive cells sectors. Therefore the Accessing Countries will work together to facilitate harmonization of inspection, authorization and vigilance systems, while strengthening cooperation and trust among the respective national programs. The transfusion, transplants and of assisted reproduction systems have been carefully reviewed at European level; however, in view of a common legal framework, each Member Country is responsible for the implementation of the requirements required by the European Directives on Quality and Safety. This Joint Action will offer the opportunity to work together for the first time with the aim of standardizing the systems of the Member Countries, focusing on compatibility, harmonization and inter communicability of the different national programs . VISTART which will run for 36 months, also comes from previous EU funded projects, coordinated respectively by National Transplant Center and the National Blood Centre. Entrusting the coordination to two technical bodies of the Ministry of Health, established at the National Institute of Health, testifies the leadership taken by our country at the European level. A further recognition of the quality and safety achieved by our systems in the field of blood transfusion, organ donation and transplantation of organs, tissues and cells. Brochure: LAYMAN_BROCHURE_Vistart_final Web site: https://vistart-ja.eu/
ETN (European Transplant Network)

In 2003, during a meeting of Ministers of Health of the countries that were about to enter the Union at the time, a particular emphasis was placed on the problem of the shortage of organs and on the advantages that greater collaboration between foreign countries would have produced in this area. On the basis of this recommendation in 2004 a large group of countries, including Italy and Czech Republic, Austria, Greece, Poland, Hungary, Slovakia, Latvia, Lithuania, Estonia, Cyprus and Malta, signed a common statement that turned to the inter-governmental organization European Transplant Network, whose secretariat was initially established in Prague and since 2005 in Italy. Since 2004, the ETN has carried out a series of activities in four main areas, training (seven training courses for healthcare professionals for a total of 240 participants), the presentation of joint scientific projects (MODE, ACCORD) the development of joint initiatives for the exchange of organs (projects COORENOR and FOEDUS, and bilateral agreements), as well as the care of the legal aspects.

Bilateral agreements

Previous to the birth of the Italian National Transplant Center, various bilateral agreements between Italian inter regional ares or regions and some European countries were already put in place. Over the last thirteen years, CNT tried to systematize the agreements of this kind, bringing them within the framework of cooperation agreements signed by the healthcare Italian Ministry of Health, while respecting the interest of some clinical centers for international cooperation. These agreements relate mainly to the training, exchanges of surplus organs and caring of a limited number of patients, usually urgent cases, pediatric or particular complex cases, and for which no adequate care could take place in their the country of origin, but always in accordance with a budget of resources that does not penalize any participating country. Currently such agreemets are in place with Poland, Slovakia, Malta, Greece, and are sporadically exchange of organs with many other countries, such as the area of Eurotransplant, France, Spain.

SAT (South Transplant Alliance)
The main objective of the South Transplant Alliance is to establish a formal accord of cooperation between the competent bodies for the donation and transplantation of human substances for countries in the South West of Europe. The idea of this cooperation arises from the interest of Italy, France and Spain to find shared solutions to the same problems, the three organizations have common bioethical principles in the field of organ donation and transplantation, all have a similar organizational and regulatory system, and their business is largely based on the transplant from cadaveric donor. These forms of agreement are much more interesting, in the light of the transposition of the European Directive 53/2010 on the quality and safety in the donation and transplantation of organs from the Member States, which makes it particularly necessary to develop common strategies among national organizations. The promoters of this initiative are the national organizations for transplantation of Italy, France and Spain, namely CNT, the Agence de la biomédecine and Organizacion Nacional de Transplantes.
NOTIFY
In September 2010 the NOTIFY Project was initiated as a joint venture by WHO and the Italian National Transplant Centre. The project aims to promote and improve vigilance systems for the full scope of Medical Products of Human Origin (MPHO), including organs, blood, tissues, cells, gametes and embryos. The focus of the work has been the development of the NOTIFY Library (www.notifylibrary.org) , an open access database of reliably documented didactic cases of adverse occurrences arising with the clinical application of MPHO, from donation to follow-up of donors and recipients. Cases are analysed, linked to their source reference (scientific publications, formal vigilance programmes) and regularly updated by editorial groups of international experts in the fields of transplantation, transfusion and assisted reproduction. The experts work in health authorities and professional societies across the globe and in all MPHO sectors. Expert analysis focuses in particular on how the adverse occurrence was recognised and how it is shown to have been associated with the donation, process or clinical application of the MPHO. Occurrences analysed include transmitted infections, malignancies, donor reactions, clinical complications and process associated incidents. Sharing the lessons learned from adverse outcomes can allow significant process improvements for the greater protection of donors and patients. These benefits apply where the incident occurred but also anywhere else where an identical or similar incident might occur. The purpose of the NOTIFY Library is not to be a register of registries but to be a comprehensive tool, describing all types of reactions or events that might have didactic value and assist in the estimation of risk. Apart from being an important tool for vigilance management, the library promotes good vigilance policy and practice for MPHO and is building a global network of experts that are learning from each other. All organisations, authorities or professional societies, that work on the safety and quality of MPHO are invited to support this didactic initiative by signing the attached statement of support.

Website: www.notifylibrary.org


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