MINISTERS’ DEPUTIES

CM Documents

CM(2021)171

14 December 2021[1]

1422nd meeting, 19 January 2022 6 Social cohesion   6.3 European Directorate for the Quality of Medicines and HealthCare (EDQM)[2] b. Abridged report of the 26th meeting of the European Committee on Organ Transplantation (Partial Agreement) (CD-P-TO) – (7-8 October 2021) Item to be considered by the GR-SOC at its meeting on 13 January 2022

 

Opening of the meeting and adoption of the agenda

The European Committee on Organ Transplantation (CD-P-TO) held its 26^th meeting by videoconference on 7 and 8 October 2021 with Dr Franz Immer and Dr Akila Chandrasekar in the Chair.

The agenda of the meeting is contained in Appendix 1. The full report of the meeting, including the list of participants, is available from the EDQM.

Item for decision by the Committee of Ministers

1.          The Committee adopted a draft legal instrument recommending that member States develop donation after circulatory determination of death (DCDD) programmes due to their potential to significantly increase the donor pool and thus the number of available organs. The draft would be submitted to the Committee of Ministers for adoption.

List of items for information by the Committee of Ministers

2.          Due to the Covid-19 pandemic, the meeting was held by videoconference. Due to the limitations of this format, and with a view to keeping the length of the meeting as short as possible, only topics and projects that required an immediate decision in order to move ahead were included on the agenda.

3.         No conflicts of interest were declared by any of the participants in accordance with EDQM rules and procedures.

4.          The Committee was reminded that the stakeholder consultation of the Guide to the quality and safety of organs for transplantation was ongoing and were kindly requested to submit their comments or requests for changes in writing using the official form. Following this step, a final consensus version of the guide would be produced by the drafting group and would be submitted to the Committee for adoption, without any further room for changes. Thus, the Secretariat stressed the importance of a thorough revision by member States at that time.

5.          The Newsletter Transplant 2021 had been published. Members of the Committee were reminded the electronic version was available free of charge on the EDQM FreePub website[3] and paper copies could be ordered from the EDQM WebStore[4]. National representatives at the CD-P-TO were requested to inform their Ministries of Health and to work internally to ensure the maximum dissemination and use of publications among donation and transplantation professionals in their home countries and within their organisations and/or professional associations. Some of the data for both organ donors and recipients had been collected disaggregated by sex. This was deemed as an important step towards a better knowledge of the issue and, where relevant, the adaptation of national policies accordingly. In this vein, a dedicated group had prepared a scientific paper analysing this gender-disaggregated data from all 69 reporting countries and interpreting its relevance in the field; it would be submitted for publication in a scientific journal shortly. The Committee agreed on the value of collecting additional information from Council of Europe member States in a sex-disaggregated manner. Thus, in addition, a tailored questionnaire aimed at expanding the dataset would be finalised, taking into account the comments received, and would be disseminated among Council of Europe member States in the coming months. Preliminary results would be presented during the next meeting.

6.          The Committee had agreed to work on a new project to map reimbursement and compensation practices vis-à-vis living donors. Following the dissemination of a tailored survey, a landscape analysis would be presented at the next plenary meeting.

7.          The Committee was working on analysing the many factors influencing family refusal to organ donation from a deceased relative, including the timing of recognition and declaration of brain death, the timing and methodology of the family interview and the national legislation in place. A draft overview of current national practices was presented. Once the data had been refined, the findings would be published. Subsequently, tailored recommendations to address barriers to consent to organ donation and promote best practices would be elaborated.

8.          Transplant registries, which systematically collect long-term transplant outcomes, including donor and recipient confounding factors, were important to gain knowledge on the impact of this treatment modality. Furthermore, combining data from multiple national registries in a European database would maximise their value. In light of this, the Committee agreed to work on the elaboration of a recommendation supporting the establishment and maintenance of harmonised transplant registries and international data sharing. Considering that it would be essential for the collected activity data to be harmonised among reporting countries, the group would consider elaborating technical appendices including a minimum dataset and standardised definitions. A draft recommendation would be discussed during the next plenary meeting.

9.          The CD-P-TO had worked on benchmarking national policies and practices related to access of non-residents to national/regional deceased donor waiting lists. This was a matter of great importance as member States needed to provide adequate and humanitarian solutions for non-resident patients while meeting the transplantation needs of their own resident patients, whose chances of receiving the needed organ would be impacted by the influx of non-resident patients onto national/regional waiting lists. Therefore, the CD-P-TO had performed a study to understand the dimensions of the phenomenon in the pan-European setting and its impact on national waiting times for transplantation, and to learn the different strategies used by member States to address the subject. The complete results of this work, comprising information from 28 countries, had been published in a scientific journal[5]. This data, available for the first time in the European setting, would shed light on the phenomenon and provide valuable information to support the development of suitable and fair policy decisions.

10.        The network of National Focal Points (NFPs) on travel for transplantation would meet on 18 November 2021 via videoconference. During this meeting, the data submitted to the EDQM International Database on Travel for Transplantation pertaining to the years 2015-2019 would be discussed. This international exchange of information would help to better understand the phenomenon of travel for transplantation, the long-term outcomes and potential risks to both individuals and public health, and to identify possible hotspots of transplant tourism. Some member States appeared as destinations for potentially unethical transplant procedures and this required careful investigation by the countries involved (i.e. the countries of origin and destination of patients). Thus, Council of Europe member States which had not yet nominated their NFP[6] or whose NFPs were inactive[7] were requested to make/revise their appointments at their earliest convenience so they could actively participate in the network and in all necessary investigations, as required. Countries outside the Council of Europe who wished to join the network would be considered upon request. They were reminded that NFPs should be based at the existing national transplantation body or, alternatively, at the Ministry of Health in those member States where a national transplantation body did not exist or was not in charge of following up on transplantation activities.

11.        Physical examination of deceased donors was used in conjunction with review of medical history, interviews with donor families, autopsy reports and screening tests as part of a comprehensive donor evaluation to maximise the safety and quality of donated organs and tissues. An overview of the current practices in member States was presented and would be prepared for publication in a scientific journal. Subsequently, guidance on best practices and technical recommendations would be elaborated for incorporation in the Guide to the quality and safety of tissues and cells for human application and the Guide to the quality and safety of organs for transplantation. Drafts would be reviewed at the next meeting. In addition, the possibility/need to develop training on how to perform a physical examination of potential deceased organ and tissue donors would be discussed on that occasion.

12.        A booklet aimed at providing clear, accurate and balanced information on oocyte and sperm preservation, elaborated with the support of the European Society for Human Reproduction and Embryology (ESHRE), had been published[8] .The aim of this booklet was to increase health literacy with regard to this topic and to support informed decisions by individuals considering this treatment. Delegations were encouraged to disseminate this booklet in their home countries and were reminded that permission to translate it into their native languages would be granted upon request. 

13.        The results of the survey to analyse donor protection measures vis-à-vis non-partner gamete donors in member States would be presented during the next meeting. Subsequently, tailored recommendations would be elaborated.

14.        Achieving self-sufficiency based on voluntary unremunerated donation and security of supply, as well as timely and equitable access to safe transplantation, are important national and European goals. A realistic assessment of supply and needs is fundamental for the rational, fair and effective distribution of tissues and cells and, most importantly, to avoid overreliance on a few countries outside or inside of Europe. However, at present we only have a fragmented and incomplete picture of tissue and cell activity. In the context of its standing co-operation with the European Commission, the EDQM had identified a minimum dataset to accurately evaluate tissue and cell activity in member States. The Committee discussed a draft legal instrument recommending the collection of this type of data and proposing a minimum harmonised dataset. Some changes would be included in a revised version with a view to having it adopted by written procedure.[9]

15.        A booklet for the public on tissue donation from deceased donors would be elaborated and the first draft presented and discussed at the next plenary meeting.

16.        A project to benchmark donor family care (organ and tissue donors) and elaborate guidance based on best practices would be launched. Draft surveys targeted at Health Authorities and centres to assess practices would be elaborated and discussed at the next plenary meeting.

17.        Poland would confirm their interest in hosting the next European Organ Donor Day (EODD), which had been postponed for the last two years due to the Covid-19 pandemic.

18.        The Committee elected Emanuele Cozzi (IT) as the new Chair of the Committee, with expertise in the field of organs. No candidacies for the Vice-Chair position, with expertise in the field of tissues and cells, had been received. Delegations showed strong support for Akila Chandrasekar (United Kingdom), the previous Vice-Chair, to be renewed in this role. A new call for candidates would be launched and Dr Chandrasekar would remain in her position until a suitable candidate was found and elected. The Committee agreed that in the future, in order to give equal weight to the organs and tissues and cells fields, the Chair and Vice-Chair positions would alternate between candidates from the two fields.

19.        The date and format of the next CD-P-TO meeting would be confirmed at a later stage depending on the epidemiological situation.

Appendix 1

AGENDA

1.       Introduction by the Chairperson

         1.1          Adoption of the agenda

         1.2          Report of the previous meeting of the CD-P-TO (25^th)

2.       Administrative issues

         2.1          Conflicts of Interest

         2.2          Working methods of intergovernmental committees

         2.3          Terms of Reference 2022-2025

         2.4          Ongoing consultation of the Guide to the quality and safety of organs for transplantation (8^th ed.)

3.       ‘Tour de Table’ new Members

4.       Gender Aspects in Transplantation

         4.1          Analysis of the Newsletter Transplant disaggregated data collection

         4.2          Expanded disaggregated data collection

5.       Donation after circulatory determination of death

         5.1          Draft legal instrument addressing DCDD programmes

6.       New project proposals

         6.1          Timing of deceased organ donor family approach in CoE member States

         6.2          Donation and transplantation registries

         6.3          Elaboration of a booklet about tissue donation

         6.4          Donor family care (organ and tissue donors)

7.       Access of non-residents to deceased donor waiting lists for organ transplantation

8.       Network of National Focal Points on travel for transplantation and International database on patients transplanted abroad

9.       Newsletter Transplant 2021

10.     Controversies and new frontiers in donation and transplantation

         10.1        Risk-based assessment of uterus transplantation

11.     Update on the revision of the EU Tissue and Cell Legislation

12.     Benchmarking physical examination practices of organ and tissue donors

13.     Booklet on Fertility Preservation: A guide for people facing an illness or life events that may affect their fertility

14.     Scientific article on protection of haematopoietic progenitor cell donors

15.     Elaboration of a legal text recommending the collection of a harmonised minimum dataset to benchmark tissue and cell activity

16.     Elections for Chair and Vice-Chair

17.     European Organ Donation Day (EODD)

 

18.     Date and venue of the next meeting

        

         27^th plenary meeting of the CD-P-TO, 7 and 8 April 2022, EDQM, Strasbourg