Ministers’ Deputies
CM Documents

CM(2009)204 18 December 20091
_________________________

1076 Meeting, 3 February 2010

6 Social cohesion

6.5 European Directorate for the Quality of Medicines (EDQM)
b. European Committee on Organ Transplantation (CD-P-TO)
i. Abridged report of the 5th meeting (Berlin, 2-3 October 2009)
ii. Draft terms of reference of the CD-P-TO

Item to be prepared by the GR-SOC at its meeting on 19 January 2010
_________________________

1. The 5th CD-P-TO meeting chaired by Dr Per Pfeffer (Norway) took place in Berlin on 2nd and 3rd October 2009. The agenda of the meeting is appended (Appendix 1).

2. The CD-P-TO elected its new chair, Dr Per Pfeffer (Norway) and its new vice-chair,
Dr Günter Kirste (Germany).

3. The CD-P-TO took note of the scheduled date for the end of the activity period (2007-2009) allocated by its terms of reference and decided to apply for extension of the programme and for adoption of new terms of reference by the Committee of Ministers of the Council of Europe. A progress report will be prepared and used by the Committee to monitor its progress and refine its working programme for the next activity period.

4. At this meeting, the new CD-P-TO representatives for Hungary, United Kingdom and the European Commission were introduced. Experts from the United Network for Organ Sharing (UNOS, USA), the European Society for Organ Transplantation (ESOT), the Ibero-American Council of Organ Donation and Transplantation and the Council of Europe Steering Committee on Bioethics (CDBI) also attended.

5. The ongoing projects and the basis for cooperation with the EU and the WHO were monitored. Promising cooperation fields were explored. Further to successful completion of preparatory actions on agreement on the set up of an assistance programme referred to as “Black Sea Area Initiative” aimed at the development of regulatory and organisational frameworks was reached and budgetary aspects will be looked in the coming months.

6. The CD-P-TO made substantial progress in the performance and in the elaboration of its work programme.

7. An addendum (Criteria for preventing the transmission of neoplastic diseases in organ donation) to the 3rd edition of the Guide to safety and quality assurance for the transplantation of organs, tissues and cells was published in English and in French in April 2009.

8. The ad-hoc experts group, that was created to explore the preparation of the 4th edition of the Guide to safety and quality assurance for the transplantation of organs, has not met. Dr Kirste (Germany), chairman of this group, proposed inter alia to await for progress of other international initiatives in the field of infectious disease transmission by organ transplantation. The guide should be reviewed extensively in the course of 2010 in the light of the outcome of these new studies.

9. Collection of data from 2008 on organ, tissues and cells donation and transplantation in European countries and in other regions of the world was completed and corresponding information were published under the common aegis of the Organización Nacional de Transplantes (ONT, Madrid, Spain) and the Council of Europe in the Transplant Newsletter issue 2009. A strong plead was made to determine uniform data definitions in Europe and the ways to evaluate the population of countries as accurately as possible.

10. Findings and observations in surveys on transplant tourism, transplantation to non-residents and national donor registers were discussed. Due to limited reply rates, it was decided to proceed with these enquiries.

11. On 4 and 5 October 2009, the joint 11th European Day and 5th World Day for Organ Donation and Transplantation took place in Berlin, hosted by Deutsche Stiftung Organtransplantation (DSO) and organised in collaboration with the Council of Europe/EDQM, the European Commission and the Foundation Fairtransplant. The event was held in combination with the 10th International Society for Organ Donation and Procurement (ISODP) and with the 16th European Transplant Coordinators Organisation (ETCO) annual meetings. The chair and several members of the CD-P-TO took part in a specific session dedicated to the European Perspectives.

12. The Committee was reminded of the decision to organise the following European Day for Organ Donation and Transplantation in Georgia on 23 October 2010. The Committee approved the invitation to organise the following European Day for Organ Donation and Transplantation in Greece in 2011.

13. On 13 October 2009, an expert report on a joint Council of Europe and United Nations study on “Trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs” was presented in New York. The 4 authors were assisted by the Secretariat of the Council of Europe Convention on Action against Trafficking in Human Beings and the Office of the Special Adviser on Gender Issues and Advancement of Women at the United Nations Department of Economic and Social Affairs. Representatives of the secretariats of the World Health Organization and the United Nations Office on Drugs and Crime, as well as the European Directorate for the Quality of Medicines & HealthCare and the Health and Bioethics Department of the Council of Europe, shared their experience, research, reports and data. The CD-P-TO has strongly supported this initiative through participation of its Spanish representatives, Dr Dominguez Gil and Dr Rafael Matesanz.

14. The Committee decided to start new projects, notably a survey on organ procurement to non-residents, the development of a model for the celebration of the European Day for Organ Donation and Transplantation aimed at better focusing on the impact on public awareness, as well as a study on the issue of double listing on national waiting lists. The survey on international organ exchange has been put on hold until the EU directive on organ transplantation that will set a common regulatory frame in the EU member states is adopted.

Appendix 1

Agenda

1. ADOPTION OF THE AGENDA

2. ADMINISTRATIVE ISSUES

2.1. Terms of reference, Rules of procedure

2.2. Elections of the new chair and new vice-chair

2.3. Activity report of the CD-P-TO

3. NEWS FROM MEMBER STATES AND OBSERVERS – COOPERATION

3.1. Tour de table: new initiatives in member states and observers

3.2. EU activities in the field - Regulation (European Directive for Organ Transplantation) - Cooperation (action plan): Anna Pavlou (Directorate General Health and Consumer Protection - Unit  C6 Health Measures, European Commission)

3.3. European projects in the technical field

3.4. WHO activities in the field - Cooperation: L. Noël (World Health Organisation, Switzerland), R. Matesanz (Organización Nacional de Transplantes (ONT), Spain)

3.5. UNOS activities in the United States of America - Areas for potential cooperation: T. Pruett (UNOS)

3.6. Ibero-American Council of Donation and Transplantation: R. Garcia-Gallont (Hospital General San Juan de Dios, Guatemala)

3.7. Joint Council of Europe-United Nations study on organ trafficking: B. Dominguez-Gil (Organización Nacional de Transplantes (ONT), Spain)

    3.8. Follow up of the International Summit on Transplant Tourism and Organ Trafficking, Istanbul, Turkey, 30 April-2 May 2008: G. Kirste (Deutsche Stiftung Organtransplantation (DSO), Germany)

4. ASSISTANCE ACTIVITIES

4.1. Assistance to Moldova

    4.1.1. Feedback from Council of Europe-sponsored - Seminar on ethical and organisational aspects of organ transplantation, 2-3 December 2008, Chisinau, Moldova. Follow up actions needed: I. Codreanu (Republican Clinical Hospital, Moldova)

    4.1.2. Reports from France (K. Laouabdia, Agence de la Biomédecine, France) and Italy (A. Nanni Costa, Italian National Transplant Centre, Italy) for Moldova

    4.2. Black Sea Area Initiative - Cooperation

5. TECHNICAL ACTIVITIES

5.1. European Day of Organ Donation and Transplantation

    5.1.1. 2009 - Programme of the 11th European Day of Organ Donation and Transplantation: G. Kirste (Deutsche Stiftung Organtransplantation (DSO), Germany)

    5.1.2. 2010 - 12th European Day of Organ Donation and Transplantation: G. Tomadze (Georgian Association of transplantologists/Ministry of Health of Georgia)

    5.1.3. 2011 - Organisation of the 13th European Day of Organ Donation and Transplantation

5.2. Transplant Newsletter 2009

    5.2.1. Update on International figures on Organ Donation and Transplantation 2008 campaign - data reporting and publication

      5.2.1.1. Transplant Newsletter: R. Matesanz (Organización Nacional de Transplantes (ONT), Spain)

      5.2.1.2. EUROCET - ANC: A.  Nanni Costa (Italian National Transplant Centre, Italy)

6. NATIONAL ORGANISATIONAL ASPECTS

6.1. International organ exchange - Safety and quality for organs, tissues and cells transportation: A. Rahmel (Eurotransplant)

7. MIGRATION, MINORITIES, ORGAN TRAFFICKING

7.1. Survey on Transplant Tourism and Organ Trafficking - follow up: K. Laouabdia (Agence de la Biomédecine, France)

7.2. Transplantation for non-residents and migration issues - follow up: A. Nanni Costa (Italian National Transplant Centre, Italy)

7.3. Procurement on non-resident: R. Matesanz (Organización Nacional de Transplantes (ONT), Spain)

7.4. Double listing: A. Rahmel (Eurotransplant), K. Laouabdia (Agence de la Biomédecine, France), I. Haertel (CDBI)

8. HEART BEATING DONORS

8.1. Heart-beating donors - national registers: B. Haase-Kromwijk (Dutch Transplantation Foundation, Netherlands)

9. LIVING DONORS

9.1. Booklet on living donor transplantation (advice for Authorities): Ph. Morel (Hôpital Cantonal Universitaire, Switzerland)

10. NON-HEART BEATING DONORS

10.1. Non-heart-beating donors - follow up: B. Dominguez-Gil (Organización Nacional de Transplantes (ONT), Spain)

11. SAFETY AND QUALITY

11.1. Guide: Safety and quality for organs, tissues and cells

    11.1.1. 3rd edition & addendum: secretariat

    11.1.2. 4th edition - update on current status: G. Kirste (Deutsche Stiftung Organtransplantation (DSO), Germany)

    11.1.3. Working Group members

11.2. Criteria on neoplastic disease screening - plans for revision of the 4th edition: R. Matesanz and B. Dominguez-Gil (Organización Nacional de Transplantes (ONT), Spain)

12. RESEARCH - PROSPECTIVES

12.1. Islet isolation and transplantation: Ph. Morel (Hôpital Cantonal Universitaire, Switzerland)

13. ANY OTHER BUSINESS

13.1. Donor derived Disease gathering - update of informal meeting of 31 August 2009: G. Kirste (Deutsche Stiftung Organtransplantation (DSO), Germany)

13.2. Models for European Day of Organ Donation and Transplantation: D. Avsec-Letonja (Slovenija Transplant, Slovenia)

13.3. Any other questions

    13.3.1. Presentation of history of European Day and World Day of Organ Donation and Transplantation: Ph. Morel (Hôpital Cantonal Universitaire, Switzerland)

14. DATES OF THE NEXT MEETINGS

Appendix 2

Draft of the terms of reference of the CD-P-TO

Fact sheet

Name of Committee:

European Committee (Partial Agreement) on Organ Transplantation (CD-P-TO)

Compliance with Resolution Res(2005)47:

Yes, except for the term of office of Chairperson (three years instead of one, renewable once).

Programme of activities: project(s)

Under the authority of the Committee of Ministers, in its composition restricted to the representatives of the States members of the Partial Agreement of the Convention on the Elaboration of a European Pharmacopoeia, the Committee shall undertake the following actions:

    examine questions related to the transplantation of organs, tissues and cells, notably as regards quality and safety standards and their implementation;
    examine the organisational structures concerning organ transplantation with a view to improve these structures and address the causes of organ shortage;
    develop links between the exchange organisations throughout Europe;
    propose ethical quality and safety standards on professional practices;
    ensure the transfer of knowledge and expertise and develop competencies of experts through training and networking;
    contribute to awareness-raising of the population in general on organ donation for transplantation.

Project relevance:

Third Summit Action Plan Chapter II – Strengthening the security of European citizens, Articles 3. Combating trafficking in human beings and 6. Promoting ethics in biomedicine.

The importance of elaborating and promoting the principle of non-commercialisation of organ donation, strengthening measures to avoid organ trafficking and, in general, elaborating high ethical, quality and safety standards in the field of organ transplantation:

Project added value:

    The 3rd Conference of European Health Ministers on Organ Transplantation (Paris, 1987) established as a practical objective for the Council of Europe to study the ethical aspects of organ transplantation in Europe;
    the Council of Europe is a leading regional agency in this field with a number of recommendations and 3 editions (including addenda) of the Guide to safety and quality assurance for organs, tissues and cells and its valuable contribution on the Additional Protocol to the Convention on Human Rights and Bioethics;
    the European Donation and Transplantation Day (established on a Council of Europe proposal);
    the importance of assistance activities, in particular, in non-EU member states;
    the EC Directives take into account Council of Europe documents;
    duplications are avoided by close co-operation with the EC and the WHO.

Financial information:

The Committee in plenary meets at least once a year. The sending authorities of the member states will bear the travel and subsistence expenses for their representatives’ participation in the meetings of the
CD-P-TO.

The budget for this activity is set out in Part 5 of the document CM(2009) 130 Vol 3 which was adopted by the Committee of Ministers on 25 November 2009 (CM/Res (2009) 30).

Terms of reference of the European Committee (Partial Agreement) on organ transplantation (CD-P-TO)

1.

Name of Committee:

European Committee (Partial Agreement) on organ transplantation (CD-P-TO)

2.

Type of Committee:

Steering Committee (Partial Agreement)

3.

Source of terms of reference:

Committee of Ministers, in its composition restricted to the representatives of the States members of the Partial Agreement of the Convention on the Elaboration of a European Pharmacopoeia

4.

Terms of reference:

 

Having regard to:

-

the importance of elaborating and promoting the principle of non-commercialisation of organ donation, strengthening measures to avoid organ trafficking and, in general, elaborating high ethical, quality and safety standards in the field of organ transplantation;

-

the Convention on Human Rights and Biomedicine (ETS No. 164) and its Additional Protocol on Transplantation of Organs and Tissues of Human Origin (ETS No. 168);

-

the orientations of the 7th Conference of Health Ministers (Oslo, 2003) entitled “Health, Dignity and Human Rights”.

 

Under the authority of the Committee of Ministers, the Steering Committee (hereinafter the “CD-P-TO”) shall undertake the following actions:

a.

    examine questions related to the transplantation of organs, tissues and cells, notably as regards quality and safety standards and their implementation; in particular by pursuing the regular update, revisions and further developments of the “Guide to safety and quality assurance for the transplantation of organs, tissues and cells”, its regular publication and promote its implementation;

b.

examine the organisational structures concerning organ transplantation with a view to improving these structures and addressing the causes of organ shortage;

c.

develop links between the exchange organisations throughout Europe;

d.

    propose quality and safety standards on professional practices, taking into account ethical aspects;

e.

ensure the transfer of knowledge and expertise and develop competencies of experts through training and networking;

f.

contribute to awareness-raising of the population in general on organ donation for transplantation;

g.

approve proposals for resolutions prepared for adoption by the Committee of Ministers in its composition restricted to the representatives of the States members of the Partial Agreement of the Convention on the Elaboration of a European Pharmacopoeia. The latter may submit proposals for consideration by the Committee of Ministers in its full composition;

h.

    monitor implementation of the above-mentioned activities and in particular revise and update any resulting documents concerning organ transplantation, including the guide to safety and quality assurance for organs, tissues and cells;

i.

co-operate with the Steering Committee on Bioethics (CDBI) in the implementation of all aspects of transplantation covered by the Convention on Human Rights and Biomedicine (ETS No. 164) and its Additional Protocol on transplantation of organs and tissues of human origin (ETS No. 168);

j.

while taking account of the progress of its work, prepare, under its own responsibility, proposals for the Programme of Activities for the coming years.

5.

Composition:

5.A

Members

 

Governments of Council of Europe States members of the Convention on the Elaboration of a European Pharmacopoeia are entitled to appoint a representative with expertise in area covered by these terms of reference. Each member shall have one vote.

The sending authorities of the member states will bear the travel and subsistence expenses for their representatives’ participation in the meetings of the CD-P-TO.

A special assistance programme including support for attending relevant meetings can be applied to those member states which present a justified request to the CD-P-TO. If the request is approved, the travel and subsistence expenses will be borne by the EDQM’s specific budgetary appropriations.

5.B

Participants

 

The following committees may each send representatives to meetings of the CD-P-TO, without the right to vote and at the charge of the corresponding heads of the Council of Europe budget:

- European Health Committee (CDSP);
- Steering Committee on Bioethics (CDBI).

The CD-P-TO may invite representatives of other committees and bodies of the Council of Europe to specific meetings depending on the agenda of the respective meeting, without the right to vote and at the charge of the corresponding heads of the Council of Europe budget.

5.C

Other participants

i.

Council of Europe member states other than mentioned above under 5.A and other states with observer status with the European Pharmacopoeia Commission may send a representative to the meetings of the CD-P-TO, without the right to vote or defrayal of expenses.

ii.

A special assistance programme including support for attending relevant meetings can be applied to those member states which present a justified request to the CD-P-TO. If the request is approved, the travel and subsistence expenses will be borne by the EDQM’s specific budgetary appropriations.

iii

The European Union is entitled to appoint a representative to meetings of the CD-P-TO, without the right to vote or defrayal of expenses.

iv.

The World Health Organisation (WHO) may send a representative to meetings of the CD-P-TO, without the right to vote or defrayal of expenses.

5.D

Observers

i.

The following international NGOs may sent a representative to meetings of the CD-P-TO, without the right to vote or defrayal of expenses:

- Eurotransplant;
- Scandiatransplant.

ii.

Any other international non-governmental organisation active in the field may ask for observer status with the CD-P-TO and be allowed to send a representative to its meetings, without the right to vote or defrayal of expenses.

The observer status is granted on the basis of a unanimous decision by the CD-P-TO. In the event where unanimity is not reached, the matter may be referred to the Committee of Ministers at the request of two-thirds of the members of the Committee.

6.

Working methods and structures:

 

The Committee shall meet in plenary at least once a year. Meetings between the chairpersons and project leaders (referred to as Bureau) shall be planned at least once a year. Extraordinary meetings of the CD-P-TO can be convened upon motivated request by the chairpersons.

The chair is elected for a period of three years. The chair shall not immediately be eligible thereafter for re-election. While he/she holds office, the chair shall not be a member of any delegation. The travel and subsistence expenses of the chair are borne by the specific budgetary appropriations of the CD-P-TO.

The CD-P-TO shall define its rules of procedure.

With a view to reaching its objectives, the CD-P-TO may arrange consultations, by means of hearings or by any other means, as appropriate.

7.

Duration:

 

1 January 2010 – 31 December 2012.

Note 1 This document has been classified restricted until examination by the Committee of Ministers.


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