{"id":454,"date":"2024-04-25T12:54:26","date_gmt":"2024-04-25T12:54:26","guid":{"rendered":"http:\/\/annualreport.edqm.eu\/?page_id=454"},"modified":"2024-06-10T20:50:03","modified_gmt":"2024-06-10T20:50:03","slug":"organs-tissues-cells","status":"publish","type":"page","link":"https:\/\/annualreport2023.edqm.eu\/en\/organs-tissues-cells\/","title":{"rendered":"Organs, tissues and cells | Quality & safety of substances of human origin"},"content":{"rendered":"\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t\t\t
<\/div>\n\t\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Quality & safety of substances of human origin<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Organs, tissues and cells<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

The EDQM\u2019s transplantation activities, overseen by the European Committee on Organ Transplantation (CD-P-TO), include the collection of international data and monitoring of practices in Europe, knowledge sharing between member states (health authorities, professional organisations and experts) through training and networking, and the elaboration of reports and guidance documents.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Work programme<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Fight against unethical transplantation practices<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Transplantation abroad may be a viable, ethical solution for some patients in exceptional, justified circumstances, after referral of the patient\u2019s need for a transplant through official channels and when supported by solid medical, organisational or social reasons. Other patients with no or limited access to transplantation in their home countries may, out of desperation, resort to transplantation abroad outside of official channels. Travel for transplantation becomes \u201ctransplant tourism\u201d, and thus unethical, when it involves trafficking or when resources (including organs) are devoted to providing transplants to non-resident patients, undermining a country\u2019s ability to provide transplant services for its own population. Travel for transplantation is currently a largely unexplored topic.<\/p>

The EDQM Network of National Focal Points on Travel for Transplantation (NETTA) was established in line with Resolution CM\/Res(2013)55 on establishing procedures for the collection and dissemination of data on transplantation activities outside a domestic transplantation system<\/span><\/a> and Resolution CM\/Res(2017)2 on establishing procedures for the management of patients having received an organ transplant abroad upon return to their home country to receive follow-up care<\/a><\/span><\/span>. The terms of reference for this network were approved in 2023. To date, 34 countries have designated national focal points (NFPs), which provide information to the Registry of International Travel for Transplantation Activity (RITTA) on an annual basis. The international exchange of information about patients who have travelled abroad to receive an organ transplant serves to shed light on this phenomenon, identify possible transplant tourism hotspots, profile donors and recipients, and provide insight into the quality of transfer of care and its impact on post-transplant outcomes. By the end of 2023, RITTA contained information on almost 900 patients.<\/p>

In 2023, the Council of Europe Convention against Trafficking in Human Organs<\/a><\/span> was signed by Azerbaijan and ratified by France. To date, 15 states have ratified this convention and another 12 have signed it.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Technical guides<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

The EDQM develops and provides comprehensive technical standards and guidance in organ donation and transplantation and the application of tissues and cells for a broad range of healthcare professionals, inspectors and national authorities. They are published in the form of the Guide to the quality and safety of organs for transplantation<\/span><\/span><\/em><\/a> (the \u201cOrgan Guide\u201d, 8th edition, 2022) and the Guide to the quality and safety of tissues and cells for human application<\/span><\/span><\/em><\/a> (the \u201cTissue and Cells Guide\u201d, 5th edition, 2022), both of which are regularly revised and updated to ensure they keep pace with scientific developments and regulatory changes. The dedicated working groups of internationally recognised experts, working under the aegis of the CD-P-TO, entrusted with this invaluable and highly rewarding mission, worked actively in 2023 on the drafting of the 9th edition of the Organ Guide and the 6th edition of the Tissue and Cells Guide, scheduled for publication in 2024 and 2025, respectively.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t
\n\t\t\t\t\t