Ministers’ Deputies
CM Documents

CM(2009)203 18 December 20091
_________________________

1076 Meeting, 3 February 2010

6 Social cohesion

6.5 European Directorate for the Quality of Medicines (EDQM)
a. European Committee on Blood Transfusion (CD-P-TS)
i. Abridged report of the 5th meeting (Amsterdam, 5-6 November 2009)
ii. Draft terms of reference of the CD-P-TS

Item to be prepared by the GR-SOC at its meeting on 19 January 2010
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1. The 5th meeting of the CD-P-TS, chaired by Dr Jeroen de Wit (Netherlands), took place in Amsterdam at the premises of Sanquin on 5th and 6th November 2009. The agenda of the meeting is appended (Appendix 1).

2. The CD-P-TS elected its new chair, Dr Rut Norda (Sweden) and its new vice-chair, Dr Margerethe Heiden (Germany).

3. The CD-P-TS 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. The new CD-P-TS representatives for Switzerland, Turkey and the European Commission were introduced to the Committee. Five experts in the field, Dr Gilles Folléa (Établissement Français du Sang (EFS), France), Daniel Quagliaroli (Laboratoire français du Fractionnement et des Biotechnologies (LFB), France), Wim de Kort and Masja de Haas (Sanquin, Netherlands) and Stanley Urbaniak (Regional Transfusion Centre, Scotland, United Kingdom) also attended the meeting.

5. The ongoing projects and the basis for cooperation with the EU and the WHO were monitored. Cooperation has been established with the EU to start a European Programme of External Quality Assessment: voluntary participation to Proficiency Testing Studies and audits or visits will be offered to testing laboratories of Blood Establishments in the forthcoming years. Implication into the South-Eastern Europe Health Network (SEE) project “Increasing regional self-sufficiency in relation to safer blood and blood components” led by Romania is currently under evaluation. The Council of Europe also associated itself more closely to major events to raise public awareness on blood donation, notably the World Blood Donor Day.

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

7. The CD-P-TS took note of the completion of the restructuration process for the “Guide to the Preparation, Use and Quality Assurance of Blood Components” and adopted the final version of the 15th edition. Its publication is scheduled for the beginning of 2010. It is also foreseen to prepare several language versions in the course of 2010 and 2011 in order to allow the widespread use of this guide. The preparation of the 16th edition has already started and will be ongoing in 2010.

8. On 24-25 April 2009, a symposium on “Optimal Clinical Use of Blood Components” took place in Wildbad Kreuth, Bavaria, Germany. It was organised under the aegis of the EDQM/Council of Europe in collaboration with the German Regulatory Agency for the control, evaluation and supervision of biological medicines (Paul-Ehrlich Institute) and the University of Munich. Participation of 110 experts representing 38 countries (including Russia, Turkey and USA) as well as the European Manufacturers Associations of plasma derivates and the European Haemophilia Consortium (EHC). In 2010, the proceedings of the meeting and proposals for a follow-up action plan should be disseminated.

9. Reporting and analysis of data on collection testing and use of blood components from European countries and from other regions of the world are completed for the years 2006 and 2007. A trend analysis on data collected in the years 2001-2007 will be prepared. It is foreseen to publish this information on the Council of Europe/EDQM website.

10. A progress report was presented for the ad hoc working group on blood donor management working on the issues related to the constant shortage in blood and blood components and subsequent limitation in transfusion therapies as well as the heterogeneous levels of donation in respective countries. The working group, which requested a prolongation of its mandate, has collected information and generated a self assessment questionnaire for blood banks and establishments. As a first step, a survey will be organised in 2010. Follow up actions (e.g. a workshop) are also planned.

11. The ad hoc working group responsible for the settings up of a central database on stocks of frozen blood of rare blood groups, available for international exchange, has presented a pilot data base to the Steering Committee. The working group plans to integrate real data in the database and to launch it for public use in the forthcoming months. A workshop aimed at recruiting potential participants to build up a functional and complete international database and informing users is planned.

12. A new survey on “Pathogen inactivation/reduction procedures” has been performed. Its outcome should be available at the beginning of 2010. A symposium aimed at supporting policy makers regarding the impact of implementation of pathogen inactivation/reduction techniques on safety and quality of blood components is scheduled for 2010.

13. The Committee decided to start new projects in the fields of “Risk behaviours having an impact on blood donor management” and “Health Economics in the field of Blood Transfusion.” A project on “Defining the consent of illiterate or foreign nationals not mastering the language” has been initiated and will be further developed with the active cooperation of the Council of Europe Bioethics Steering Committee (CDBI).

Appendix 1

Agenda

1. ADOPTION OF THE AGENDA

2. NEWS FROM MEMBER STATES AND OBSERVERS – COOPERATION

    2.1. Tour de table: hot topics in the field of blood transfusion

      2.1.1. Pandemic influenza
      2.1.2. Specific question from Sweden on deferral criteria for donors: R. Norda (Clin. Immunology and Transfusion Medicine, Uppsala University Hospital, Sweden)

    2.2. European Commission: B. Kaltenbrunner-Bernitz (DG Sanco, Belgium)

    2.3. WHO

      2.3.1. Update: N. Dhingra (WHO Headquarters, Switzerland)
      2.3.2. Melbourne declaration on 100% voluntary non-remunerated donation of blood and blood components: N. Dhingra (WHO Headquarters, Switzerland)
      2.3.3. Pandemic influenza guidelines: A. Padilla (WHO Headquarters, Switzerland)

    2.4. USA: A. Williams (Food and Drug Administration (FDA))

3. ETHICAL ISSUES

    3.1. Obtaining the consent of illiterate, strangers not mastering the language of the country or blind blood donors

      3.1.1. Survey from the Steering Committee on Bioethics (CDBI), presented at the 37th meeting of the CDBI
      3.1.2. Ethical and legal considerations: M. Vesga Carasa (Centro Vasco de Transfusion y Tejidos Humanos, Spain)

4. EUROPEAN SELF SUFFICIENCY

    4.1. Volunteer donors to yield hyperimmune anti-D prophylaxis plasma

      4.1.1. Introduction: J. de Wit (Sanquin, Netherlands)
      4.1.2. Anti-D immunisation and treatment, background information: S. Urbaniak (University of Aberdeen, United Kingdom)
      4.1.3. WHO Guidelines for immunisation: A. Padilla (WHO Headquarters, Switzerland)
      4.1.4. Monoclonal antibodies development - update and potential as alternative to anti-IG: D. Quagliaroli (Laboratoire français du Fractionnement et des Biotechnologies (LFB), France)
      4.1.5. Optimal use of anti-D: M. de Haas (Sanquin, Netherlands)

5. QUALITY ASSURANCE ACTIVITIES

    5.1. Update on the set up of Proficiency Testing Programme for testing labs in blood centres: secretariat

    5.2. Expert Committee on Biological Standardisation: A. Padilla (WHO Headquarters, Switzerland)

6. TECHNICAL ACTIVITIES

    6.1. Blood donor management

      6.1.1. Ad Hoc Advisory Group on Blood Donor Management in Europe: G. Folléa (Établissement Français du Sang (EFS), France)

        6.1.1.1. Report on status of work
        6.1.1.2. Self assessment questionnaire

      6.1.1.3. Study outline for 2010-2011

      6.1.2. Update on DOMAINE: W. de Kort (Sanquin, Netherlands)

    6.2. Guide to the preparation, use and quality assurance of blood components 15th and 16th editions: C. van der Poel (Sanquin, Netherlands)

      6.2.1. 15th edition

        6.2.1.1. Report of last meeting of experts group for the guide (GTS)
        6.2.1.2. Public enquiry for 15th edition - Outcome
        6.2.1.3. Adoption

          - Standards
          - Principles

      6.2.2. 16th edition

        6.2.2.1. Clinical use of blood: F. Nascimento (Instituto Portugues de Sangue, Portugal)

    6.3. Kreuth initiative – Meeting of 24-25 April 2009

      6.3.1. Outcome of the meeting: secretariat
      6.3.2. Follow up activities: secretariat

    6.4. Questionnaire on the collection, testing and use of blood components – Data collection, analysis and publication: C. van der Poel (Sanquin, Netherlands) and M.P.  Janssen (Utrecht University, Netherlands)

      6.4.1. 2005 – final report
      6.4.2. 2006 – report – status
      6.4.3. 2001-2005 – trend analysis – report
      6.4.4. 2001-2006 – trend analysis – status
      6.4.5. 2007-2008 – data reporting campaign (methods, status)

    6.5. Pathogen inactivation/reduction procedures – update on methodologies – 2009 survey

      6.5.1. Outcome of the enquiry
      6.5.2. Plans for the organisation of a workshop on Pathogen Reduction

    6.6. European bank of frozen cells: L. Muylle (AFMPS, Belgium)

      - status - feasibility study: secretariat

7. ADMINISTRATIVE ISSUES

    7.1. Activities report of CD-P-TS

    7.2. Terms of reference

    7.3. Elections of new chair and new vice-chair

8. ANY OTHER BUSINESS

Appendix 2

Draft terms of reference of the CD-P-TS

Fact sheet

Name of Committee:

European Committee (Partial Agreement) on blood transfusion (CD-P-TS)

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 human blood transfusion, notably as regards quality and safety standards and their implementation, including collection, preparation, storage, distribution and appropriate use;
    assist member states in improving and, if needed, in restructuring their blood transfusion services by promoting principles of voluntary non-remunerated donations;
    propose ethical, safety and quality standards on professional practices and on specifications of products;
    ensure the transfer of knowledge and expertise and develop competencies of experts through training and networking;
    monitor practices in Europe and assess epidemiological risks, in particular of the emergence of new transmissible diseases linked to blood and blood components;
    promote quality assurance with the latest developments including the updating of the technical appendix to Recommendation R (95) 15 on the preparation, use and quality assurance of blood components;
    ensure availability of rare blood products by means of the European Data Base and Bank of Frozen Blood of Rare Groups, according to the European Agreement on the Exchange of Therapeutic Substances of Human Origin (ETS No. 026).

Project relevance:

The importance of elaborating and promoting high ethical, safety and quality standards in the field of blood transfusion:

    the European Agreement on the Exchange of Therapeutic Substances of Human Origin (ETS No. 026);
    the Recommendation R (95) 15 of the Committee of Ministers to member states on the preparation, use and quality assurance of blood components.

Project added value:

    the Council of Europe is a leading regional agency in this field with a number of recommendations and 15 editions of the Guide to the preparation, use and quality assurance of blood components and Questionnaire on the collection, testing and use of blood and blood components in Europe;
    the EC Directives take into account and refer to the Council of Europe documents;
    the Council of Europe organises, as a joint programme with the EU, a new external quality assessment international programme (PTS/QA) for the testing laboratories in the blood services;
    the Council of Europe organises important assistance activities, in particular, in non-EU member states;
    duplication is avoided by the 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-TS.

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).

Draft terms of reference of the European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS)

1.

Name of Committee:

European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS)

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 high ethical, safety and quality standards in the field of blood transfusion;

-

the European Agreement on the Exchange of Therapeutic Substances of Human Origin (ETS No. 26);

-

the Convention on Human Rights and Biomedicine (ETS No. 164);

-

Recommendation R (95) 15 of the Committee of Ministers to member states on the preparation, use and quality assurance of blood components;

-

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-TS”) shall undertake the following actions:

a.

examine questions related to human blood transfusion, notably as regards quality and safety standards and their implementation, including collection, preparation, testing, storage, distribution and appropriate use;

b.

assist member states in improving and, if needed, in restructuring their blood transfusion services by promoting principles of voluntary non-remunerated donations;

c.

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

d.

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

e.

    monitor practices in Europe and assess epidemiological risks, in particular of the emergence of new transmissible diseases linked to blood and blood components;

f.

    promote quality assurance with the latest developments including the updating of the technical appendix to Recommendation R (95) 15 on the preparation, use and quality assurance of blood components; in particular by pursuing the regular update, revisions and further developments of the “Guide to the preparation, use and quality assurance of blood components”, its regular publication and promote its implementation;

g.

    ensure availability of rare blood products by means of the development of a European Data Base and Bank of Frozen Blood of Rare Groups, taking into account the European Agreement on the Exchange of Therapeutic Substances of Human Origin (ETS No. 26);

h.

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;

i.

    monitor the implementation of the above-mentioned activities and in particular revise and update any resulting documents concerning blood transfusion;

j.

co-operate with the Steering Committee on Bioethics (CDBI) in the implementation of the Convention on Human Rights and Biomedicine (ETS No. 164) as far as blood transfusion is concerned;

k.

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 to 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-TS.

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-TS. 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-TS, 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-TS 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-TS, 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-TS. 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-TS, 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-TS, without the right to vote or defrayal of expenses.

5.D

Observers

 

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

Observer status is granted on the basis of a unanimous decision by the CD-P-TS. 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 CD-P-TS.

6.

Working methods and structures:

 

The CD-P-TS 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-TS can be convened upon a 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-TS.

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

With a view to reaching its objectives, the CD-P-TS 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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