Committee of Ministers

Comité des Ministres

 

Strasbourg, 2 September 1997 Restricted

CM(97)126

 

For consideration at the 602nd meeting of the Ministers’ Deputies

(30 September 1997, B level, item 6.1)

 

EUROPEAN HEALTH COMMITTEE

(CDSP)

 

41st meeting

Strasbourg, 24-25 June 1997

 

List of items discussed and decisions taken

 

1. The European Health Committee (CDSP) held its 41st meeting on 24-25 June 1997 in Strasbourg. The list of participants and agenda are set out in Appendices I and II respectively.

 

The meeting was chaired by Dr P. Wium (Norway).

 

The CDSP proceeded to elect a new chairman to replace Prof. H. Roscam Abbing (Netherlands) and three new members of the Bureau to replace Dr H. Voigtlaender (Germany), Dr E. Mintiens (Belgium) and Dr Vasco Pinto Reis (Portugal).

 

Dr Per Wium (Norway) was elected Chairman ; Dr Margot Muller (Luxembourg), Dr S. Moriconi (Italy) and Mr A. Ernst (France) were elected members of the Bureau.

 

 

2. The CDSP then examined the state of implementation of its work programme for 1997.

 

It adopted the following draft recommendations:

 

- on xenotransplantation (Appendix III)

 

- on liver transplantation from living related donors (Appendix IV)

 

  • - on the development and implementation of quality improvement systems together with an explanatory memorandum (Addendum)
  • and transmitted them to the Committee of Ministers for adoption.

     

    The CDSP also adopted the draft Recommendation concerning the ethical and organisational aspects of health care in prison and draft explanatory memorandum, prepared jointly with the European Committee on Crime Problems (CDPC) and which is set out in Addendum II to doc CDPC (97) 17 and 18, subject to the amendments set out in Appendix V to this report.

     

    It also authorised the following publications under the responsibility of their authors :

     

    - a state of the art report on xenotransplantation;

     

  • - a state of the art report on screening of organ donors to prevent the transmission of neoplastic diseases;
  • - a report on the activities of blood banks related to bone marrow transplantation;

     

  • - a report on the collection and use of human blood and plasma in the non Community Council of Europe countries;
  • - a report on the development and implementation of quality improvement systems.
  • The CDSP then adopted new terms of reference for the Select Committee of Experts on Quality Assurance in Blood Products (SP-R-GS) (Appendix VI) and for a Committee of Experts on criteria for the management of waiting lists and waiting times for health care (Appendix VII) and transmitted them to the Committee of Ministers for approval.

     

    The CDSP equally adopted a draft opinion on Assembly Recommendation 1317 (1997) on vaccination in Europe and transmitted it to the Committee of Ministers for consideration (Appendix VIII).

     

     

    3.1 The CDSP took note that a delegation composed of the Chairperson of the CDSP and of the Committee of Experts on Blood Transfusion and Immunohaematology (SP-HM) and members of the Secretariat had met officials from the European Commission (DGV) on 21 February 1997 to coordinate the work programmes of the two Organisations.

     

    In this context it recalled that an exchange of views on public health had been held at the 9th Quadripartite meeting between the Council of Europe and the European Commission. The meeting had stressed that particular attention should be given to cooperation and coordination in relation to human organs, tissues, blood and blood products.

     

    It also took note that Article 129 of the Maastricht Treaty as amended at the Amsterdam Summit would give the European Commission a competence in the area of health and instructed the Secretariat to follow developments closely to ensure proper coordination and avoid overlap of activities.

     

    The CDSP therefore regretted the repeated absence of the European Commission from its meetings. It also regretted that up to now no reply was forthcoming as to whether the European Commission intended to sign the new technical protocol to Agreement n° 26 and that the Council of Europe had not been invited to the Commission's meeting on donor selection and training.

     

    3.2 The CDSP welcomed that a CDSP Bureau delegation would meet the Bureau of the CDBI on 4-5 November 1997 in Paris, to discuss cooperation and proper coordination of work between the two bodies.

     

    4. The CDSP then examined and agreed on its work programme for 1998, which was essentially a continuation of the 1997 programme. It took note of the proposal to carry out in the current year, with funds available for this year, an activity foreseen in the 1998 programme, and agreed that the course on the development and use of health technologies be held during 1997.

     

    It also agreed that the Council of Europe should build up a network for an exchange of information between member States on a number of issues relating to patients' rights, patient participation and equity in access.

     

    5. The CDSP agreed to hold its 42nd meeting in Strasbourg on 25-26 November 1997.

     

     

    APPENDIX I

     

    LIST OF PARTICIPANTS/LISTE DES PARTICIPANTS

     

     

    ANDORRE/ANDORA

    M. Josep BURGUES MONTSERRAT c/o Ministère de la Santé et du Bien-Etre - ANDORRA LA VELLA

     

    ALBANIE/ALBANIA

    ----------

     

    AUTRICHE/AUSTRIA

    Dr Johann-Friedrich KURZ, Director, Ministry of Labour, Health and Social Affairs - VIENNA

    Mrs Verena GREGORICH-SCHEGA, International Relations, Ministry of Labour, Health and Social Affairs - VIENNA

     

    BELGIQUE/BELGIUM

    M. Marc DE WIN, Conseiller, Ministère des Affaires sociales, de la Santé publique et de l'Environnement - BRUXELLES

    Mme le Dr Chantal GUEUR, Médecin à la Direction générale de la Santé - Direction générale de la Santé - BRUXELLES

     

    BULGARIE/BULGARIA

    Dr Kancho TCHAMOV, Chef du département "Politique de Santé et Collaboration internationale" Ministère de la santé, SOFIA

     

    CHYPRE/CYPRUS

    --------

     

    CROATIE/CROATIA

    Prim Dr Miroslav GLUHINIC, Main Secretary of the Ministry of Health - ZAGREB

    Prof Ivan VODOPIJA - President of the National Health Council - ZAGREB

     

    REPUBLIQUE TCHEQUE/CZECH REPUBLIC

    Mrs Alexandra KRALOVA - Senior Official - Department of Foreign Relations -Ministry of Health -PRAHA 2

     

    DANEMARK/DENMARK

    Dr Jorgen Steen ANDERSEN, National Board of Health COPENHAGEN

    Ms Elise QUAADE - Head of Section - Ministry of Health COPENHAGEN

     

    ESTONIE/ESTONIA

    Prof. Raul TALVIK - Head of Dept of Anaesthesiology and Intensive care - Tartu University - EE TARTU

     

     

    FINLANDE/FINLAND

    Dr Olli SIMONEN, Government Counsellor, Department of Prevention and Promotion - Ministry of Social Affairs and Health - HELSINKI

    Ms Marja-Liisa PARTANEN, Senior Counsellor, Department for Social and Health Services - Ministry of Social Affairs and Health - HELSINKI

     

    FRANCE

    M. André ERNST - Chargé de mission pour les Affaires européennes - Direction générale de la Santé - Ministère de l'Emploi et de la Solidarité - PARIS

    M. Xavier COYER, Chef du Secteur des Affaires européennes - Délégation aux affaires européennes et internationales, Ministère de l'Emploi et de la Solidarité - PARIS

     

    ALLEMAGNE/GERMANY

    Mr Helmut VOIGTLAENDER, Director, Directorate for EC Affairs, International Relations, Federal Ministry of Health - BONN

    Mrs Marinetta DROBEK - Division on International Cooperation in the Field of Health - Federal Ministry for Health - BONN

     

    GRECE/GREECE

    Mrs Jenni KOUREA KREMASTINOU, Professor of Public Health, National School of Public Health, -ATHENS

    Mme Constantina POLITIS, Assistant Professor of Haematology, Director of the 3rd Regional Blood Transfusion Center, Regional General Athens Hospital "George Gennimatas" ATHENS

     

    HONGRIE/HUNGARY

    Mrs Katalin SARKANY, Deputy Director, Département de la Coopération Internationale et de la Coordination de l'intégration européenne, Ministère du Bien-Etre, BUDAPEST

     

    ISLANDE/ICELAND

    Mr David A. GUNARSSON, Secretary General, Ministry of Health and Social Security, REYKJAVIK

     

    IRLANDE/IRELAND excusée

     

    ITALIE/ITALY

    Dr Stefano MORICONI - Medical Officer - Ministry of Health - International Relations Office and Community Policies - ROME

     

    LETTONIE/LATVIA

    Dr Viktors JAKSONS, Director of Health Affairs Department - Ministry of Welfare RIGA

     

    LIECHTENSTEIN excusé

     

    LITHUANIE/LITHUANIA

    Dr Robertas PETKEVICIUS, WHO Liaison Officer - Adviser to the Minister - Division of International Relations, Ministry of Health - VILNIUS

     

     

    LUXEMBOURG

    Dr Margot MULLER, Médecin-Chef de Division, Direction de la Santé, LUXEMBOURG

     

    MALTE/MALTA

    Dr Raymond XERRI - Director - Department of Health Policy and Planning - Health Division - 6, FLORIANA

     

    MOLDOVA /MOLDOVA

    -----------

     

    PAYS-BAS/NETHERLANDS

    Prof. Dr H.D.C. ROSCAM ABBING, Legal Counsellor, Health Law, Executive Board, Ministry of Health, Welfare and Sport, RIJSWIJK

    Mrs A. GORIS, Ministry of VWS, International Affairs, THE HAGUE

     

    NORVEGE/NORWAY

    Dr Per WIUM - Chief Medical Adviser - National Board of Health OSLO

    Dr Jens ESKERUD - Adviser, Ministry of Health and Social Affairs, OSLO

    Mrs Marie ALSROD, Senior Executive Officer, Norwegian Board of Health, OSLO

     

    POLOGNE/POLAND

    Dr. Andrzej ZBONIKOWSKI, Head of Health Policy and Health Services, Ministry of Health and Social Welfare WARSAW

     

    PORTUGAL

    Prof. Vasco Pinto REIS, Direction générale de la Santé, LISBONNE

     

    ROUMANIE/ROMANIA

    Dr Victor OLSAVSZKI, Head of international Relations Division, Ministry of Health,BUCHAREST

     

    FEDERATION DE RUSSIE/RUSSIAN FEDERATION

    Prof. Felix VARTANIAN, Vice-Rector, Russian Academy for Advanced Medical Studies, Ministry of Health of Russian Federation, MOSCOW

     

    SAINT MARIN/SAN MARINO

    --

    ESPAGNE/SPAIN

    Mrs Esther RODRIGUEZ , Head of the Service of International Affairs, Ministry of Health, MADRID

     

    REPUBLIQUE SLOVAQUE/SLOVAK REPUBLIC

    Ludovit LACA, MD, PhD, Roosvelt Hospital, BANSKA BYSTRICA

     

    SLOVENIE/SLOVENIA

    Dr Vlasta MOCNIK DRNOVSEK, Adviser to the Minister, International Relations Department, Ministry of Health, LJUBLJANA

     

    SUEDE/SWEDEN

    Dr Lennart RINDER, Director, National Board of Health and Welfare, STOCKHOLM

     

    SUISSE/SWITZERLAND

    Dr Stéphanie ZOBRIST, Affaires internationales, Office fédéral de la Santé publique, 3003

    BERNE

     

    EX-REPUBLIQUE YOUGOSLAVE DE MACEDOINE/THE FORMER YUGOSLAV

    REPUBLIC OF MACEDONIA

    Dr Anastasia POPOSKA, Medical Doctor, Ministry of Health, SKOPJE

     

    TURQUIE/TURKEY

    Dr Selcuk METINER, General Directorate of Curative Services - Ministry of Health, ANKARA

     

    ROYAUME-UNI/UNITED KINGDOM

    Mr. A. KINGHAM, Section Head, International Branch, Department of Health, LONDON

     

    UKRAINE

    Mr Anatol BERNATSKIY, International Economy Consultant to the Ministry of Health, KIEV

     

    *

    * *

     

    RAPPORTEUR

    Dr. Rafael MATESANZ, Director General, INSALUD, MADRID

     

    *

    * *

    COMMISSION DES COMMUNAUTES EUROPEENNES/

    COMMISSION OF EUROPEAN COMMUNITIES - excusée

    COUNCIL OF EUROPEAN COMMUNITIES/

    CONSEIL DES COMMUNAUTES EUROPEENNES

    Mr Jürgend NEISSE, administrateur, DG1, Direction générale des affaires sociales, BRUXELLES

     

    *

    * *

     

    OBSERVATEURS/OBSERVERS

    ORGANISATION MONDIALE DE LA SANTE/WORLD HEALTH ORGANISATION (Europe) excusée

     

    SAINT SIEGE/HOLY SEE

    Dr F. D. CHARLES, STRASBOURG

    Dr R. LEHMANN, STRASBOURG

     

     

    FEDERATION DES SOCIETES DE LA CROIX ROUGE ET DU CROISSANT

    ROUGE/ FEDERATION OF RED CROSS AND RED CRESCENT SOCIETIES

    Dr Ian F. YOUNG, Directeur du Département des Programmes de sang, GENEVE

     

    *

    * *

     

    DIRECTION DES AFFAIRES SOCIALES ET ECONOMIQUES /

    DIRECTORATE OF SOCIAL AND ECONOMIC AFFAIRS SECRETARIAT

    Mr Robin GUTHRIE, Director of Social and Economic Affairs

    Mr H. SCICLUNA, Head of Health and Social Policy Division

    Mr Karl-Friedrich BOPP, Administrator

    M. Piotr MIERZEWSKI, Administrator

    Mrs C. WENDELBO, Administrative Assistant

    Mme C. STEINECKER, Assistant

    Health and Social Policy Division

    Directorate of Social and Economic Affairs

    Council of Europe

     

     

     

    APPENDIX II

     

    AGENDA

     

    1. OPENING OF THE MEETING

     

    2. ADOPTION OF THE AGENDA

     

    3. REPORT OF THE BUREAU

     

    4. ELECTION OF CHAIRPERSON AND MEMBERS OF THE BUREAU

     

    5. DECISIONS OF THE COMMITTEE OF MINISTERS

     

    6. COOPERATION WITH OTHER INTERNATIONAL ORGANISATIONS

     

  • A. IMPLEMENTATION OF THE CURRENT WORK PROGRAMME
  • 7. POSITION AND ROLE OF THE INDIVIDUAL

     

    7.1 Patient's rights

     

  • 7.1.1 The use of medical examinations in the field of employment and insurance -
  • 7.1.2 Committee on Psychiatry and Human Rights
  • 7.2 Patient's choice

     

  • 7.2.1 Coordinated Research Study on the development of models of structures for patient/citizen participation
  • 7.2.2 Health promotion and health education - the ENHPS

     

  • 8. THERAPEUTIC SUBSTANCES OF HUMAN ORIGIN - AVAILABILITY, QUALITY AND SAFETY

    8.1 Blood Transfusion

    8.1.1. Committee of Experts on Blood Transfusion and Immunohaematology (SP-HM)

    8.1.2 Recommendation R (95) 15 on the Preparation, Use and Quality Assurance of blood components

    8.1.3 Activities of blood banks related to bone marrow transplantation -

  • a) Draft recommendation

    b) Open Forum

    8.1.4 Relations with the European Commission on the blood transfusion programme

    a) Council of Europe/European Commission meeting

    b) 9th Quadripartite meeting

    8.1.5 Task Force on the restructuring of blood transfusion services in Central and Eastern Europe

    8.1.6 Self-Sufficiency in the non-Union member State of the Council of Europe

    8.1.7 Terms of Reference for the SP-R-GS

    8.2 Organ Transplantation

    8.2.1 Committee of Experts on the Organisational aspects of cooperation in organ transplantation (SP-CTO)

  • a) Quality assurance for organs and tissues

     

    b) Meeting the Organ shortage

     

    c) New terms of reference for the SP-R-CTO

     

    d) Computer network for the exchange of livers in super urgent cases

     

    e) Protocol to the Convention on Human Rights and Biomedicine on organ transplantation

     

  • f) Safety and quality aspects of organ transplantation
  • g) Non resident patients

     

  • 8.3 Health Services
  • 8.3.1 Quality Assurance in Health Care

     

    9. EQUITY IN ACCESS

     

    9.1 Vulnerable Groups

     

  • 9.1.1 The Organisation of health care services for persons in detention
  • 9.1.2 The organisation of health care services for the elderly in institutions
  • 9.1.3 Committee of Experts on the organisation of health care for the chronically-ill

     

     

    9.1.4 Multidisciplinary Group on Dependence

     

    9.2 Management of health services

     

    9.2.1 Management of waiting lists

     

    9.3 Essential services

     

    9.3.1 Committee of experts on criteria for preventive medicine

     

    B. FUTURE WORK PROGRAMME

     

    10. PROGRAMME OF ACTIVITIES

     

  • 10.1 Programme of Activities for 1997
  • 10.2 Programme of activities for 1998

     

    C. INFORMATION

     

    11. EXCHANGE OF VIEWS AND INFORMATION

     

  • 11.1 Clearing House for issues arising out of the 5th Conference of Health Ministers

    11.2 The work of the various Bodies of the Council of Europe in the Sector of interest to the European Health Committee

  • 11.3 Demosthenes Programme

     

    D. MISCELLANEOUS

     

     

    12. SIXTH CONFERENCE OF MINISTERS

     

    13. OTHER BUSINESS

     

    14. DATE AND PLACE OF NEXT MEETING

     

     

    APPENDIX III

     

    DRAFT RECOMMENDATION No. R (97)...

     

    OF THE COMMITTEE OF MINISTERS TO MEMBER STATES

    ON XENOTRANSPLANTATION

     

    (Adopted by the Committee of Ministers on

    at the... meeting of the Ministers' Deputies)

     

    The Committee of Ministers, under the terms of Article 15.b of the Statute of the Council of Europe,

     

    Considering that the aim of the Council of Europe is to achieve greater unity between its members and that this aim may be pursued, inter alia, by the adoption of common action in the health field;

     

    Taking into account Resolution (78) 29 on the harmonisation of legislation of member States relating to removal, grafting and transplantation of human substances, the Final Text of the 3rd Conference of European Health Ministers (Paris, 16-17 November 1987) and articles 19 and 20 of the Convention on Human Rights and Biomedicine;

     

    Considering that xenotransplantation, that is, the use of living organs, tissues and/or cells from animals, whether genetically modified or not, for transplantation into humans, may become a practicable therapeutic intervention in the very near future.

     

    Aware that there is a risk of transmission of disease as a result of xenotransplantation procedures,

    Recommends that Governments of member States should establish a mechanism for the registration and regulation of the following aspects of xenotransplantation with a view to minimising the risk of transmission of known or unknown diseases and infections to either the human or animal population:

     

    i. basic research and clinical trials;

     

    ii. the source and care of animals for use in xenotransplantation;

     

    iii. xenotransplantation programmes;

     

      1.  
      2. long term follow-up and review of xenograft recipients and the xenograft source animals.

     

     

     

    APPENDIX IV

     

    DRAFT RECOMMENDATION No. R (97) ...

     

    OF THE COMMITTEE OF MINISTERS TO MEMBER STATES

    on

    LIVER TRANSPLANTATION FROM LIVING RELATED DONORS

     

    (Adopted by the Committee of Ministers on ............

    at the...... meeting of the Ministers' Deputies)

     

    The Committee of Ministers, under the terms of Article 15.b of the Statute of the Council of Europe;

     

    Considering that the aim of the Council of Europe is to achieve greater unity between its members and that this aim may be pursued, inter alia, by the adoption of common action in the health field;

     

    Considering that liver donations by live related donors saves the lives of children;

     

    Bearing in mind that, in liver transplantation with living related donors, the ethical principles concerning organ transplantation as set out in Resolution (78) 29 on the harmonisation of legislation of member States relating to removal, grafting and transplantation of human substances, and agreed at the 3rd Conference of European Health Ministers (Paris, 16-17 November 1987), should be respected under all circumstances and that fully informed consent is required from both the donor and the recipient;

     

    Mindful of the provisions of Articles 19, 20 and 21 of the Convention on Human Rights and Biomedicine;

     

    Taking account of World Health Organisation Resolution WHA 42.5 condemning the purchase and sale of organs of human origin;

     

    Recommends that governments of member States conform to the rules set out in the Appendix to this Recommendation in carrying out liver transplantation from living related donors (LRLT).

     

    Appendix to the Recommendation

     

    i) LRLT should be considered only when there is a shortage of cadaver organs i.e. when alternatives that do not carry the risks incurred by a living donor have been exhausted.

     

    On the evidence currently available LRLT should be considered only for children and should not be recommended for adults nor in an emergency situation such as fulminant liver failure.

     

    ii) Potential recipients of LRLT should have been previously assessed as suitable for cadaveric transplant and, if considered suitable for LRLT, should still be retained on the cadaveric programme in case a suitable liver becomes available. If it is unlikely that a suitable cadaveric liver will become available within the required timescale, then the patient and relatives should be informed of the possibility of LRLT.

     

    iii) The potential risks, including morbidity and mortality arising from LRLT as well as its benefits should be explained to the potential recipient and the consent of the donor should be obtained only after a full explanation of the risks of LRLT and an assessment of the donor's suitability by a third party, i.e. a "donor advocate" independent of the transplant team.

    Fully informed consent should be equally obtained from the recipient (or recipients' representative).

     

    iv) Minors and adults not having the capacity to consent to an intervention because of a mental disability, a disease or for similar reasons should not be considered as donors.

     

    v) Centres performing LRLT should have available a body of medical and non medical professionals independent of the team performing the transplant to provide guidance on ethical issues relating to LRLT. A mechanism for independent assessment of the donor should be available as a minimum requirement to ensure that he/she is not under pressure to consent.

     

    vi) LRLT should only be performed in centres with extensive experience of all aspects of liver surgery, including liver splitting techniques, adult and paediatric liver transplantation, and within the framework of a quality assurance programme.

    Centres should only perform LRLT procedures with the approval of an appropriate transplant regulatory body. The procedures should be registered with the regulatory authority and the results monitored by a recognised method of peer review (until such time as the results are acceptable).

    vii) Living related donors should not participate in medical experiments unless their objective is to evaluate the LRLT.

     

    APPENDIX V

     

    DRAFT RECOMMENDATION No. R (97) .. CONCERNING THE ETHICAL

    AND ORGANISATIONAL ASPECTS OF HEALTH CARE IN PRISON

     

    and

     

    DRAFT EXPLANATORY MEMORANDUM

     

    Amendments proposed by the CDSP at its meeting on 24-25 June 1997

    to the text adopted by the European Committee on Crime Problems (CDPC),

    and which is set out in doc CDPC (97) 17 and 18, Addendum II

     

     

    Draft Recommendation

     

    Article 4

     

    Prisoners should have access to a doctor, when necessary, at any time during the day and the night. Someone competent to provide first aid should always be present on the prison premises. In case of serious emergencies, the doctor, a member of the nursing staff and the prison management should be warned; active participation and commitment of the custodial staff is essential.

     

    Article 5

     

    Free An access to psychiatric consultation and counselling should be secured. There should be a psychiatric team in larger penal institutions. If this is not available as in the smaller establishments, consultations should be assured by a psychiatrist, practising in hospital or in private.

     

    Article 18

     

    All transfers to other prisons should be accompanied by the completed medical records. Prisoners should be informed that their medical record will be transferred. They should be entitled to object, but the final decision should rest with the doctor, in accordance with national legislation.

     

    All released prisoners should be given relevant written information concerning their health for the benefit of their family doctor.

     

    Article 63

     

    If, in the opinion of the doctor, the hunger striker's condition is becoming significantly worse, it is essential that the doctor should report this fact to the appropriate authority and take action in accordance with national legislation (including professional standards)

     

    Article 72

     

    Body searches are a matter for the administrative authorities and prison doctors should not become involved in such procedures. However, an intimate medical examination should be conducted by a doctor when there is an objective medical reason requiring her/his involvement.

     

    Draft Explanatory Memorandum

     

    Article 18

     

    When a prisoner is transferred to another prison, his/her medical records, or a detail medical report, should be transmitted to the doctor who will be treating the prisoner in future. It is important that the prisoner be informed about the transmission of medical records or reports and he/she should be given the possibility to object. However, the final decision should be that of the doctor who should be prepared to inform the prisoner about the reasons for this decision. The same should apply When the prisoner is released, with the consent of the patient concerned, all useful medical information should be communicated to the patient's general practitioner, in order to ensure appropriate medical care.

     

    Article 74

     

    This paragraph recalls basic principles for medical research as expressed in Recommendations No. R (87) 3 on the European Prison Rules (Rule 27), No. R (90) 3 on medical research on human beings (principle 7), No. R (93) 6 on prison and criminological aspects of the control of transmissible diseases including Aids and related health problems in prison (para. 16) and in the Convention on Human Rights and Biomedicine of 1997 (in particular Articles 15, 16 and 17).

     

    Although it is clearly unthinkable that prisoners, as any other persons, should be subjected, without their consent or knowledge, to experimental procedures which may damage their physical or mental health, it would be inappropriate to exclude them totally from participating in medical research. This is true in particular for persons who had been participating in clinical trials before imprisonment and for whom it seems indispensable to continue the trials during detention.

     

    In keeping with the afore-mentioned texts it is therefore essential, inter alia, that prisoners undergo medical research only if the effect of the treatment can reasonably be expected to be beneficial to their health. In order to properly implement these principles, the following safeguards should apply: informed and written consent by the prisoner, which should imply that the prisoner is not induced to participate by prospect of any privileges; possibility to withdraw this consent at any time; approval of the procedures by an appropriate ethical committee independent of both the doctor carrying them out and the prison authorities, in conformity with national legislation.

     

    APPENDIX VI

     

    SPECIFIC TERMS OF REFERENCE

     

  • 1. Name of Committee: Select Committee of Experts on Quality Assurance in Blood Transfusion Services

    (SP-R-GS)

  • 2. Type of Committee: Select Committee of Experts

    3. Source of Terms of Reference: European Health Committee (CDSP)

  • 4. Terms of Reference:

  • i. Quality Assurance

    - to continue the revision of the technical Appendix to Recommendation (95) 15 on the preparation, use and quality assurance of blood components;

    - to include a chapter on quality assurance in relation to computer technology.

    ii. Transfusion transmitted diseases

    - review of their incidence and preventive measures, including the selection of donors.

    iii. Microbiological safety

    - in blood and blood components;

    - in the laboratory;

    - new methods, in particular, molecular biology.

    iv. Exchange of sera

    - to improve proficiency testing

  • The Select Committee will submit its report to the Committee of Experts on blood transfusion and immunohaematology (SP-HM).

    5. Membership of the Committee:

    a. States whose governments are entitled to appoint members:

    Belgium, Denmark, France, Germany, Hungary, Italy, Poland, Spain, Sweden, United Kingdom, Austria (1), Finland (1), Ireland (1), Netherlands (1), Norway (1), Switzerland (1).

    b. Qualifications desirable in members: specialists in the fields covered by the terms of reference, working within the framework of a national and/or regional transfusion centre.

    Terms in office should not exceed three years, unless otherwise decided by the National Health Authorities.

    The Council of Europe's budget bears travelling and subsistence expenses for one expert per State, except for the States marked (1) which participate at their own expense.

    c. The European Commission may send a representative without the right to vote or defrayal of expenses, to meetings of the Select Committee.

    d. The following States or organisations may send representatives, without the right to vote or defrayal of expenses, to the meeting of the Committee:

    Canada, USA, WHO, International Federation of Red Cross and Red Crescent Societies, International Society of Blood Transfusion (ISBT).

    6. Working Structures and Methods:

    One meeting of 4 days every year.

    7. Duration:

    These terms of reference expire on 31 December 1998.

  • APPENDIX VII

     

    SPECIFIC TERMS OF REFERENCE

     

  • I. Name of the Committee: Committee of experts on criteria for the management of waiting lists and waiting times for health care
  • II. Type of Committee: Committee of Experts

     

    III. Source of terms of reference: European Health Committee (CDSP)

     

    IV. Terms of reference:

     

    European health care systems are faced with common problems due to a difficult economic environment. At the same time the demand for new technologies and sophisticated health care is increasing. This has led to waiting lists and waiting times for health care.

     

    This phenomenon can have a negative impact on patients on a waiting list and is a challenge for both health care systems and their managers. Waiting lists and waiting times can put pressure on the principle of equity in access to available health care services. It can also have an influence on the health of patients. Health services that are compelled to put patients on waiting lists vary, as well as the multiple factors influencing this phenomenon.

     

    1. The Committee of experts will:

     

  • - examine the terms waiting lists and waiting times for health care, and will clarify their significance for the purposes of this study;

    - examine in general the current situation in the member States with regard to waiting lists and waiting times for health care. The Committee will explore the negative effects of waiting times on the health of the individual and describe the types of health care most subjected to waiting lists. The Committee will not consider waiting lists and waiting times for organ and tissues;

    - explore the main causes of waiting lists and waiting times taking into account both medical criteria for eligibility to get on the waiting list and the organisational and managerial aspects of the health services in question;

    - consider current means of management of waiting lists and waiting times applied in various members States, the influence of funding systems and of medical criteria drawn up by the health professionals and the results obtained.

  • 2. Following this study, the Committee will draw up a report on :

     

  • - the current situation in and experience of member States with regard to means of management of waiting lists and waiting times for health care;

    - the establishment of criteria for the management of waiting lists and measures which in the short or long term may lead to a reduction of waiting lists. For example: setting medical criteria for maximum waiting time, systems of registration on the lists, medical practice guidelines, and clinical review of patients on waiting lists and their regular updating.

  • The establishment of any criteria for management of waiting lists and waiting times must to be in full respect of the principles of non-discrimination (e.g. gender, age, ability to pay, etc.) and of equity in access to health care;

     

  • - the role of the Council of Europe with regard to this phenomenon.
  • The Committee of experts will, at its first meeting, examine its terms of reference with a view to defining the field of activity and determining precisely its methods of work.

     

    V. Composition of the Committee of experts

     

    1.  
    2. The governments of all member States are entitled to appoint an expert.

     

  • The Council of Europe budget will cover travelling and subsistence expenses for one expert from each of the following member States:
  • France - health insurance

    Greece - epidemiology

    Netherlands - health law and health care consumer

    Poland - management of health care at national level

    Portugal - management of health care at local level

    Russian Federation - surgery

    Sweden - public health

    United Kingdom - hospital administration

     

    b. The European Commission may send a representative, without the right to vote or defrayal of expenses, to meetings of the Committee.

     

    c. The following organisations may send a representative, without the right to vote or defrayal of expenses, to meetings of the Committee: WHO-Regional Office for Europe.

     

    VI. Working structures and methods

     

    In view of the technical nature of the subject, it will be necessary to appoint a consultant to assist the Committee of Experts.

     

    VII. Duration: These terms of reference expire on December 1998.

     

    APPENDIX VIII

     

    EUROPEAN HEALTH COMMITTEE'S OPINION

    ON RECOMMENDATION 1317 (1997) OF THE PARLIAMENTARY ASSEMBLY

    ON VACCINATION IN EUROPE

    At the 588th meeting of the Committee of Ministers, the Ministers'Deputies asked the European Health Committee to give an opinion on Recommendation 1317 (1997) of the Parliamentary Assembly on vaccination in Europe.

     

    The European Health Committee welcomes the interest of the Parliamentary Assembly in the current public health problems.

     

    The recent reappearance in some member states of the infectious disease epidemics, once thought to be under control, reaffirms that infectious diseases do not recognise country

    borders and are still a matter of common concern to Europeans.

     

    The CDSP is currently carrying out a study on criteria for preventive policies, in which some aspects of vaccination policies are put into a broader context.

     

    The Recommendation reflects the situation relatively well.

     

    Following consultation with the WHO European Office the following comments should be made:

     

    - it is not fair to blame the transition process and the newly introduced health care reforms for the aggravation of public health problems, leaving an impression that the old political and health structures were better suited to deal with them;

     

  • - the immunization coverage is generally increasing in western Europe;
  • - the diphtheria epidemic is being controlled and primary immunisation in the former Soviet Union has been ensured (Russia is self-sufficient with regard to vaccines)

     

  • - poliomyelitis has been controlled in eastern Europe with mass immunisation
  • - in addition, certain immunisation programmes should be expanded, like the one against measles and different forms of bacterial meningitis.

     

    The CDSP supports the intention to increase awareness that there is no place for complacency and shares the concern for better implementation of the well known, evidence based public health policies and measures. There is a case to reiterate the importance of principles of solidarity, equity and protection of patients' rights.

     

    The CDSP supports the recommendations to member states, emphasizing the need to develop of national vaccination policies, improve the quality of locally produced vaccines (GMP standards) and manage vaccination programmes.

     

     

    There is a long tradition of good all-European cooperation under the WHO. Expanded Programme on Immunisation. There is therefore no need for defining a new pan-European policy on population immunisation. The next Immunisation Programme Managers' Meeting (for all 51 member states) takes place in November in Berlin.

     

    Support for eastern Europe, and recently for Albania and countries of the former Yugoslavia is given by the Interagency Immunisation Coordinating Committee (IICC) which was established in Kyobe in 1994 at the initiative of Japan and USA. It includes WHO, UNICEF, International Federation of Red Cross, Rotary International, USAID, Canada, Denmark, France, Germany, Norway and Japan.

     

    The CDSP therefore agrees with the Parliamentary Assembly that there is no place for partisan action and welcomes the call for a coordinated, coherent and concerted international action.

     

    The Council of Europe could contribute by financing participation of representatives of the Eastern Europe in meetings or courses, including those organised by a third party.

     



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