Committee of Ministers

Comité des Ministres

Strasbourg, 14 August 1998

Restricted

CM(98)143

For consideration at the 641^st meeting

of the Ministers’ Deputies

(15 September 1998, B level, item 6.5)

EUROPEAN HEALTH COMMITTEE

(CDSP)

43^rd meeting

Strasbourg 23-24 June 1998

List of items discussed and decisions taken

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

The CDSP re-elected Dr P. Wium (Norway) Chairman for another year. It also elected two new members of the Bureau to replace Prof. H. Roscam Abbing (Netherlands) and Dr A. Zbonikowski (Poland). Dr O. Simonen (Finland) and Dr F. Vartanian (Russian Federation) were elected members of the Bureau.

The CDSP welcomed a Representative of the European Commission and observers from WHO and the Federation of Red Cross and Red Crescent Societies, as well as Dr Quintana (Spain) representing the Steering Committee on Bio-Ethics (CDBI).

 

The CDSP then reviewed the state of implementation of its work programme for 1998.

In the area of blood transfusion, the CDSP adopted a draft Recommendation on the Use of Human Red Cells for Preparation of Oxygen Carrying Substances (Appendix III) and transmitted it to the Committee of Ministers for adoption.

The CDSP expressed satisfaction at the successful activities of the Task Force on the restructuring of Blood Transfusion Services in Central and Eastern European countries and took note that a mission to Bulgaria had taken place this year and that Romania and Slovenia had requested its assistance.

3. In the context of a series of studies on vulnerable groups in society, the CDSP approved a draft recommendation on the organisation of health care services for the chronically-ill (Appendix IV) and transmitted it to the Committee of Ministers for adoption.

4. The CDSP took note that in the current situation concerning the availability of livers, it was no longer necessary to have a computerised network for the rapid exchange of livers in very urgent cases. It therefore decided to discontinue the functioning of the network.

5. The CDSP discussed its Work Programme for 1999. It took note with interest of the conclusions of the Conference on Human Dignity and Social Exclusion, particularly with regard to health aspects and the creation of a new European Committee on Social Cohesion as a follow up to the 2^nd Summit of the Council of Europe.

The CDSP agreed to build close links with the new European Committee and to decided to take into account in its future work programme the concerns of the new committee once these are known. It agreed to give high priority to a study on the adaptation of health services to the demands for health care of groups in marginalised situations and to inform the European Committee on Social Cohesion accordingly.

During the debate on the work programme for 1999, the CDSP discussed the problem of the visibility of its activities and agreed to introduce in its work programme 1999 an item on the dissemination of information to the public and for awareness raising on issues which it deals with.

It adopted its Work Programme for 1999 as set out in the Draft Intergovernmental Programme of Activities.

6. In the framework of the 1999 Work Programme, the CDSP renewed the terms of reference of the following committees of experts for the years 1999-2000 :

Committee of Experts on Blood Transfusion and Immunohaematology (SP-HM) (Appendix V);

Select Committee of Experts on the Preparation, Use and Quality Assurance of Blood Transfusion Services (SP-R-GS) (Appendix VI) ;

Committee of Experts on the Organisational Aspects of Co-operation in Organ Transplantation (SP-CTO) (Appendix VII) ;

and transmitted them to the Committee of Ministers for approval.

7. The CDSP agreed to hold its next meeting on 1 and 2 December 1998.

ANNEXE I/ APPENDIX I

LIST OF PARTICIPANTS/LISTE DES PARTICIPANTS

ANDORRE/ANDORRA

ALBANIE/ALBANIA

AUTRICHE/AUSTRIA

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

Mrs Verena GREGORICH-SCHEGA, Federal Ministry of Labour, Health and Social Affairs - Vienna

BELGIQUE/BELGIUM

M. Peter MAES, Conseiller adjoint, Ministère des Affaires sociales, de la Santé publique et de l'Environnement, Bruxelles

Mme le Dr Chantal GUEUR, Directrice, Direction générale de la Santé , Bruxelles

Dr A.COCHEZ, Ministry of the Flemish Community - Health Care Administration, Bruxelles

BULGARIE/BULGARIA

Dr St KOULAKSAZOV, Chef du Département "Politique de santé et Collaboration Internationale", Ministère de la santé, Sofia

CHYPRE/CYPRUS

--

CROATIE/CROATIA

--

REPUBLIQUE TCHEQUE/CZECH REPUBLIC

Mrs Alexandra KRALOVA - Department of International Relations -Ministry of Health - Prague

Ms Petra FUNDOVA, Ministry of Health, Prague

DANEMARK/DENMARK

Dr Jorgen Steen ANDERSEN, National Board of Health, Copenhagen

Mrs Helle Hyllehoj MOLZEN, Ministry of Health, Copenhagen

ESTONIE/ESTONIA

Prof. Raul TALVIK, Head of Department, Tartu University - University Clinicum, Tartu

FINLANDE/FINLAND

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

Mrs 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

ALLEMAGNE/GERMANY

Mr Helmut VOIGTLAENDER, Director, International Relations, Federal Ministry of Health, Bonn

Mrs Marinetta DROBEK, Division of 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

HONGRIE/HUNGARY

Mrs Katalin SARKANY, Directeur adjoint, Ministère du Bien-Etre Social, Budapest

ISLANDE/ICELAND

IRLANDE/IRELAND

Dr R BOOTHMAN, Deputy Chief Medical Officer, Department of Health, Dublin

ITALIE/ITALY

Dr Stefano MORICONI, Medical Officer, Ministry of Health, Rome

LETTONIE/LATVIA

Dr Silvija PABLAKA, Head of Health Care, Ministry of Welfare, Riga

LIECHTENSTEIN

--

LITHUANIE/LITHUANIA

Ms Janina ANDRIUSKEVICIUTE, Foreign Affairs and European Integration Division, 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, Floriana

MOLDAVIE/MOLDOVA

Mr Aureliu CIOCOI, Premier Secrétaire, Direction générale de l’Intégration européenne , Ministère des Affaires étrangères , Chisinau

PAYS-BAS/NETHERLANDS

Prof. Dr H.D.C. ROSCAM ABBING, Legal Counsellor, Ministry of Health, Welfare and Sport, Rijswijk

Mrs A. GORIS, Ministry of Health, Welfare and Sport, Rijswijk

NORVEGE/NORWAY

Dr Per WIUM, Chief Medical Officer, National Board of Health, Oslo

Ms Anne L. VALLE, Deputy Director General, Norwegian Ministry of Health and Social Affairs, Oslo

POLOGNE/POLAND

Dr. Barbara BITNER,Director, European Integration and International Relations, Ministry of Health and Social Welfare, Warsaw

PORTUGAL

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

ROUMANIE/ROMANIA

Mrs Luminita POPESCU, Director, International Relations Department, 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 MACHADO, Head of the Service of International Affairs, Ministry of Health, Madrid

REPUBLIQUE SLOVAQUE/SLOVAK REPUBLIC

Mrs Anna HOLECYOVA M.D. Ph.D, Foreign Relations Dept. Ministry of Health, Bratislava

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, Berne

Mrs Florence GAILLAT ENGELI, Office fédéral de la Santé publique, Berne

EX-REPUBLIQUE YOUGOSLAVE DE MACEDOINE/THE FORMER YUGOSLAV

REPUBLIC OF MACEDONIA

Dr Anastasia POPOSKA, Medical Doctor, Medical Faculty, Skopje

TURQUIE/TURKEY

Dr Gulum ALTACA, Associate Director of Surgery, Director, Division of Organ Transplantation, Ministry of Health, Ankara

ROYAUME-UNI/UNITED KINGDOM

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

Mr Leonard LEVY, Department of Health, International Branch, London

UKRAINE

--

*

* *

REPRÉSENTANTS DU COMITÉ DIRECTEUR EN BIOÉTHIQUE/

REPRESENTATIVES OF THE STEERING COMMITTEE ON BIOETHICS

Dr Octavi QUINTANA-TRIAS, Institut national de la Santé, Madrid

COMMISSION EUROPEENNE/EUROPEAN COMMISSION

Dr G GOUVRAS, Chef d’Unité Santé Publique, Luxembourg

*

* *

CONSEIL EUROPEEN/EUROPEAN COUNCIL

*

* *

OBSERVATEURS/OBSERVERS

SAINT SIEGE/HOLY SEE

Dr F. D. CHARLES, Strasbourg

Dr R. LEHMANN, Strasbourg

*

* *

BOSNIE HERZEGOVINE/BOSNIA HERZEGOVINA

--

ORGANISATION MONDIALE DE LA SANTE/

WORLD HEALTH ORGANISATION (Europe)

Mr Heinrich WYES, Manager, Resource Mobilization, Health and Emergency Assistance, Copenhagen

FEDERATION DES SOCIETES DE LA CROIX ROUGE ET DU CROISSANT

ROUGE/ FEDERATION OF RED CROSS AND RED CRESCENT SOCIETIES

Dr Ian YOUNG, Blood Department,Geneva

*

* *

DIRECTION DES AFFAIRES SOCIALES ET ECONOMIQUES /

DIRECTORATE OF SOCIAL AND ECONOMIC AFFAIRS

SECRETARIAT

Mrs Gabriella BATTAINI-DRAGONI, Deputy Director of Social and Economic Affairs

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

Mr Karl-Friedrich BOPP, Administrator

Mr. Piotr MIERZEWSKI, Administrator

Mr. Neculai CODRU, Assistant

Mrs C. WENDELBO, Administrative Assistante

Mme C. STEINECKER, Assistante

APPENDIX II

DRAFT AGENDA

1. OPENING OF THE MEETING

2. ADOPTION OF THE AGENDA

3. REPORT OF THE BUREAU

4. ELECTION OF CHAIRPERSON AND A MEMBER OF THE BUREAU

5. DECISIONS OF THE COMMITTEE OF MINISTERS

6. COOPERATION WITH OTHER INTERNATIONAL ORGANISATIONS

6.1 European Council, WHO (Europe) and the Federation of Red Cross and Red Crescent Societies

6.2 11^th Quadripartite meeting

A. IMPLEMENTATION OF THE CURRENT WORK PROGRAMME

7. POSITION AND ROLE OF THE INDIVIDUAL

7.1 Patients’ rights

7.1.1 The use of medical examinations in the field of employment and insurance

7.1.2 Joint meeting CDBI-CDSP Bureaux

7.1.3 Committee of experts on Psychiatry and Human Rights

7.1.4 Committee of Experts on the Harmonisation of Autopsy Rules

7.1.5 Project Group on Data Protection

7.1.6 Working Parties "Protocol to the Convention"

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 Terms of reference of the SP-HM

8.1.2 Select Committee of Experts on quality assurance in blood transfusion services (SP-R-GS)

Terms of reference

Recommendation R (95) 15 on the preparation, use and quality safety on blood products – Revision of the technical Annex 1997 (the Guide)

8.1.3 Draft recommendation on the use of human red cells for the preparation of oxygen carrying substances

8.1.4 Collection and use of human blood and plasma in Europe

8.1.5 Relations with the European Commission on the blood transfusion programme

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

8.1.7 Viral inactivation of labile blood products

8.2 Organ transplantation

8.2.1 Quality Assurance for organs and tissues

8.2.2 Meeting the organ shortage

8.2.3 Computer network for the exchange of livers in super urgent cases

8.2.4 Protocol to the Convention on Human Rights and Biomedecine on organ transplantation

8.2.5 Role and function of transplant co-ordinators

8.2.6 Terms of reference of the SP-CTO

8.2.7 2^ndEuropean Transplantation Day

 

9. EQUITY IN ACCESS

9.1 Vulnerable Groups

9.1.1 The organisation of health care services for elderly persons in institutions

9.1.2 The organisation of health care services for the elderly in institutions

9.2 Management of health services

9.2.1 Committee of Experts on the management of waiting lists and waiting times

9.2.2 Seminar on the use and development of health technology

9.3 Essential services

9.3.1 Committee of experts on criteria for preventive medicine

B. FUTURE PROGRAMME OF WORK

10. PROGRAMME OF ACTIVITIES

10.1 Conference on Health and Human Rights

10 2 Programme of activities for 1999

C. INFORMATION

11. EXCHANGE OF VIEWS AND INFORMATION

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

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

11.3 Programme of activities for the development and consolidation of democratic Programme of activities stability –ADACS)

D. MISCELLANEOUS

12. SIXTH CONFERENCE OF MINISTERS

p.m.

13. OTHER BUSINESS

DATE AND PLACE OF NEXT MEETING

 

APPENDIX III

DRAFT RECOMMENDATION N° (R) 98 ….

OF THE COMMITTEE OF MINISTERS TO MEMBER STATES

ON THE USE OF HUMAN RED CELLS FOR PREPARATION OF OXYGEN CARRYING SUBSTANCES

(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 the ethical principles concerning voluntary, non-remunerated blood donation set out in Recommendation No. R (88) 4 on responsibilities of health authorities in the field of blood transfusion, No R (90) 9 on plasma products and European self-sufficiency and No. R (95) 14 on the protection of the health of donors and recipients in the area of blood transfusion;

Recalling its Recommendation No. R (93) 4 on clinical trials involving the use of components and fractionated products derived from human blood or plasma and No. R (95) 15 on the preparation, use and quality assurance of blood components;

Bearing in mind the stipulations of the Convention on human rights and biomedicine;

Recommends to the governments of member States to see to it that

1. the procurement of raw material for the preparation of oxygen carrying substances or other medicinal substances based on human blood is organized in a way that it does not hamper a steady and sufficient blood supply for transfusion purposes;

2. the procurement of such raw material should be transparent and give the donors sufficient information on the potential use of the collection;

3. the principle of voluntary, non-remunerated donation is respected and followed in all donations of blood, independent of the ultimate therapeutic use of products.

Explanatory Memorandum

to the Draft Recommendation No. R (98) …

on the use of human red cells for preparation of oxygen carrying substances

1. Introduction

Research has been going on for a long time to find oxygen carrying substances that would be devoid of the draw-backs of red cell preparations; short storage time and special temperature requirements, dependence on blood groups, and the risks, albeit very low, of transmission of infections.

The most promising substances are based on chemically cross-linked haemoglobin molecules. At least three companies have developed such compounds by using haemaoglobin derived from human red cells. All three companies are currently conducting extensive phase III clinical trials. No doubt, the haemoglobin-based oxygen carrying substances will enter the market in no so distant future.

The invention and development of new therapeutic agents is to be welcomed. However, the fact that human blood is used as raw material has raised some concerns. In the anticipation of the rapid development, the European Health Committee (CDSP) issued in 1996 a position statement on the use of human red cells for preparation of oxygen carrying substances.

The principal point of concern has been the question of sufficient number of blood donations from voluntary, non-remunerated donors. The new substances do not, with all likelihood, reduce significantly the need of red cells for transfusion purposes, but they will complement the present regimens.

2. Paragraph 1

Procurement of human red cells as raw material for the preparation of oxygen carrying substances could interfere with the blood supply for transfusion purposes. Interruptions in the blood supply may be caused and other needy patients might thus be deprived of the possibility of receiving adequate haemotherapy. Therefore, procurement of red cells must be organised in such a way which does not jeopardize a steady and sufficient supply of blood for transfusion purposes. Outdated red cells, initially intended for transfusion, or blood non-infectious but otherwise not appropriate for transfusion is suitable raw material and should be used in priority.

3. Paragraph 2

It is important that the donor knows and fully understands why he or she is asked to give the "gift of life". If blood is collected for another purpose than the customary and conventional haemotherapy, the donor must be informed of the ultimate purpose of his or her donation. Transparency in these operations is of utmost importance. The existence of different types of blood donation centres with different goals would be confusing to the prospective donor. There is evidence from the United States that two or more competing blood collection organisations in one place results in an overall reduction of donation even if the organisations would use exclusively unpaid donors.

4. Paragraph 3

The principle of voluntary, non-remunerated donation should be respected. The industry may be tempted to establish blood procurement centres with paid donors, analogous to plasmapheresis centres with paid plasma donors admitted in some countries of the world. Recruitment in a paid system may divert donors from blood centres using non-remunerated donors and may confuse public on the importance of the principle of non-remuneration.

APPENDIX IV

DRAFT RECOMMENDATION N° (R) 98 ….

OF THE COMMITTEE OF MINISTERS TO MEMBER STATES

ON THE ORGANISATION OF HEALTH CARE SERVICES FOR THE CHRONICALLY ILL

(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 a greater unity between its members in particular for the purpose of facilitating their economic and social progress;

Considering that this aim may be pursued, inter alia, by the adoption of common rules in the health field;

Having regard to Resolution (70) 16 on Social and Medico-social Policy for Old Age, Resolution (74) 31 on Health Care and Social Work for Old People Living at Home and Recommendation No R (87) 22 on the Screening and Surveillance of Elderly Persons;

Having regard to the Recommendation 1254 (1994) of the Parliamentary Assembly on the Medical and Welfare Rights of the Elderly: Ethics and Policies;

Having regard to the final text of the Fifth Conference of European Ministers of Health in Warsaw, in November 1996 on "Social Challenge to Health: Equity and Patients' Rights in the Context of Health Care Reforms";

Noting the relevance of the World Health Organisation's Targets for Health for All for the European Region and of its policy documents on improvements of health and quality of life (target 2), reducing chronic diseases (target 4), and healthy ageing (target 6);

Considering that European countries are confronted with increasing numbers of chronically ill persons due to the increase in life expectancy, demographic ageing, and life saving medical technology;

Considering that the increase in chronic conditions will result in higher demand for health care;

Considering that chronically ill persons constitute a vulnerable group in society, and that chronic conditions have serious consequences for the quality of life of the individuals and families concerned and for the community;

Recommends that the governments of member States of the Council of Europe should develop strategies aimed at ensuring high quality health care for the chronically ill at national, regional and local levels, following the guidelines set out in the Appendix to the Recommendation.

Appendix to Recommendation No. R (98) ..

I. General

(1) Strategies aimed at ensuring high quality health care for the chronically ill should:

- be adapted to the specific needs of the chronically ill;

- strengthen the autonomy of patients;

- be oriented towards the chronically ill in their own surroundings ;

-       be equitable and accessible;

-       strengthen primary and secondary prevention;

- offer continuity and flexibility;

- offer a multidisciplinary range of professional services and skills, encompassing prevention, cure and care;

-       offer support and advice to families of chronically-ill people including practical, social and emotional support;

-       offer patients training on meeting difficulties and managing their own health;

-       be evidence-based;

-       have clear and realistic targets;

- be integrated in national priorities;

- encourage the international exchange of experiences and ideas.

II. Equity and availability

High priority should be given to assuring equity and availability of health care, in particular by fixing the following targets:

(2) to ensure equity in access to health care, and to reduce financial barriers in funding and insurance, and to limit private contributions of patients to medical expenses;

(3) to satisfy the needs of the whole population, in particular the vulnerable groups;

(4) to establish criteria on managing waiting times in an adequate way to ensure and reinforce equitable access, with regard to both long term care and acute hospital care;

(5) to reduce waiting lists and shorten waiting times for long-term home care, geriatric services and institutional care in nursing homes by developing alternatives; for such purpose, long treatment and hospitalisation should, wherever possible, be avoided if patients' health may be improved by alternative treatment.

(6) to guarantee non-discriminatory treatment of the chronically ill.

 

III. Integration

Comprehensive, integrated health care policies for the chronically ill should be developed

These policies should:

(7) provide an appropriate range of care services, which are community-oriented and patient-oriented;

(8) redress the balance between "cure" oriented services and "care" oriented services, aiming at strengthening chronic care services for patients who require rehabilitation and long-term care;

(9) encourage intersectoral cooperation between health care and social welfare services not only at patient level but also at organisational levels;

(10) facilitate the links between home care, hospital care and institutional care.

 

IV. Continuity and coordination

Since chronically ill persons need health care from a wide variety of care services during a prolonged period of time, health policies should focus on continuity of care. In particular these policies should:

(11) reinforce the role of general practitioners (family physicians, primary care physicians) in coordinating community-based chronic care;

(12) reinforce the role of primary care teams in securing continuity of care;

(13) envisage financial incentives to encourage continuity and coordination of care;

(14) develop and strengthen liaisons between disciplines and services working in different sectors;

(15) involve and support the informal care systems (family, volunteers) in providing continuous care;

(16) monitor and evaluate the continuity of care, and develop adequate documentation and registration systems;

(17) develop and establish indicator systems for assessing the quality of health care for the chronically ill.

 

V. Patient organizations

Health care policies for the chronically ill should encourage the empowerment of the chronically ill and should be developed in dialogue with patient organizations.

In particular these policies should:

(18) facilitate, through financial and other assistance, the establishment of patients' organisations and create conditions to develop them;

(19) promote participation of patient organizations in informing the general public, educating and training professionals, and in developing research programmes;

(20) ensure that patient organisations be consulted systematically and play an active role in advisory functions and decision-making bodies;

 

VI. Education and training

Long-term improvements in health care are impossible without individual and collective education and information in the broadest sense. It should take into account the importance of chronicity. In particular health policies should:

(21) raise the awareness of the general public of the "chronic illness issue" by acknowledging that chronic diseases present a major challenge for public health; focal points for information on care for chronically ill would help dissemination;

(22) integrate the "chronic illness issue" on a formal and continuous basis, in the undergraduate curriculum of health and social services personnel and at post-graduate level;

(23) improve therapeutic and supportive skills to cope adequately with the needs of the chronically ill;

(24) improve multidisciplinary training to assure a comprehensive, integrated approach in the care for the chronically ill.

adjust the pediatric network as to improve the situation of the chronically ill children.

 

VII. Research

High quality care for the chronically ill needs to be founded on scientific evidence. Health policy should stimulate and support research programmes financially.

The following areas should be considered:

- fundamental research and health services research with regard to common diseases as well as rare diseases;

- epidemiology, causes and consequences of specific diseases and multi-pathology;

- unravelling relationships between chronic disease-processes and ageing-processes;

- health inequalities;

- long-term, longitudinal studies;

- cost-effectiveness studies, not only of innovative programmes but also of well established health care programmes;

- development of coping mechanisms among chronically ill and their families;

- methods, interventions and strategies of providing support to the chronically ill and their families and of making the public aware of their needs;

- international comparative studies and exchange of results.

 

VIII. Implementation

(27) Member States should endeavour to implement these recommendations, by making full use of existing structures and adjusting them to present needs.

 

 

Appendix

Draft explanatory memorandum to the Recommendation No .R (98) …

1. General considerations.

Health care policies in European countries are confronted with increasing numbers of chronically ill patients due to epidemiological and demographical transitions, and life saving medical technology. The impact of chronic diseases on public health and health care will lead to transformations in policy targets.

The main targets of the care for the chronically ill are directed at effective prolongation of life, accompanied by the best possible quality of life, and the best possible social integration. Measures to ensure high quality health care may considerably benefit the health and quality of life of the chronically ill.

At present public health policies are primarily focused on specific diseases and there is an urgent need for governments to develop a health policy directed also at common issues affecting the chronically ill, in particular diminished quality of life, multi-morbidity, complex health care demands and long-term care dependency.

The objectives of the strategy for high quality care include:

- to ensure equity in health care, and availability of health care;

-      to achieve justifiable resource allocation;

-      to improve the quality of life of chronic patients;

- to provide integrated comprehensive care, encompassing prevention, cure and care;

- to guarantee continuity and coordination of care;

-      to reach a balance between the growing demand and the limited supply;

- to promote the participation of patients in health care and strengthen their role;

- to support informal care givers;

- to raise awareness by providing information, education and training;

- to stimulate fundamental and care research;

- to provide a further impetus to implement standards for high quality care of the chronically ill.

Chronic diseases are prominent among the elderly population but younger age-groups are also confronted with chronic conditions. They encompass a wide range of chronic somatic and psychiatric disorders. Chronic disorders and conditions have a differential impact on patients and societies and the chronically ill take different places on the continuum from health to illness and from independent to dependent living, and hence have varying health care demands.

Measures aimed at ensuring high quality care encompass the whole continuum of care, including health promotion, prevention, medical care, rehabilitation, nursing care, psychosocial support, aids, informal care and support from fellow patients. In particular, health services activities for the chronically ill are strongly interrelated with social services activities.

Concept of the "chronically ill"

Chronic conditions encompass a broad range of diseases and disorders which are irreversible, incurable, without a prospect of recovery, and which are on average of a long duration. Obviously, there is a wide variation in the consequences of chronic conditions for people's daily functioning and health care. Not all persons with a chronic disease are ill or limited in their daily functioning, nor are they all extensive users of health care. Some patients, however, are disabled to such an extent that they are fully dependent and need institutional care in nursing homes. Persons with chronic diseases take up different positions on the continuum from health to illness and from independent to dependent living, and hence have different health care needs. Identifying these needs is important in developing models of appropriate chronic care.

The group of chronically ill persons differs in several respects from the group of handicapped persons. An analytic framework for the discussion of the similarities and differences between both groups could be derived from the WHO model of the International Classification of Impairments, Disabilities and Handicaps (ICIDH). As long as it sufficed to record merely the occurrence of diseases in terms of either recovery or fatal outcome, the International Classification of Diseases (ICD) provided a valuable instrument. A definition of the long-term non-fatal consequences requires different concepts, provided for by the new classification. The definition of chronically ill persons includes the path from disability to handicap. Chronically ill persons could be considered as handicapped if they are also at a societal disadvantage (e.g. many stroke patients). Likewise, handicapped persons can be regarded as chronically ill only if the handicap is directly related to chronic diseases (e.g. persons with hearing or visual impairments are not chronically ill).

The broad perspective

The Recommendation focuses on common issues of the chronically ill in relation to health care.

- Focus on common issues

Studying the shared problems of chronically ill persons is an essential change of perspective. It implies a problem definition that crosses the boundaries of care services. Obviously, each chronic condition is accompanied by its specific problems. However, the difficulties which many chronically ill persons have to face in every day life have a lot in common. In identifying generic issues we have to redirect our focus from specific diseases to the common consequences of chronic diseases. We need to focus on complications and co-morbidity, functional impairments, long-term disability, psychological distress and diminished quality of life. Early therapeutic action should be taken to limit the effects of the chronic diseases and to prevent resulting handicaps.

- Focus on health care

The shared problems of chronically ill persons are related to a broad range of domains. An integrated approach demands efforts from the health sector, social sector, research community, labour sector and many other sectors.

Chronically ill persons are an important target group of health care. They need health care for a prolonged period of time and from a wide variety of health care services in the field of medical care, rehabilitation and long-term care. The health care demands are not only increasing in quantity but also in complexity. The conventional distinctions between prevention, cure and care, between primary and secondary medical care, and between professional care and informal care seem to dissolve in the face of the complex health problems of chronically ill patients. These persons need high-quality health care, that may not bring about cure but must aim to improve quality of life.

Main areas of concern

The Recommendation identifies the following areas of concern in providing appropriate health care to chronically ill persons:

a. equity and availability;

b. integration;

c. continuity and coordination;

d. patient organisations;

e. education and training;

f. research;

g. implementation.

II. Equity and availability

(2) International experiences in the field revealed a number of obstacles related to financial barriers in funding and insurance and compulsory private contributions of patients. These financial barriers are a real threat to assuring equity in access to health care.

(3) Research has consistently demonstrated that chronic diseases are more prevalent among the elderly, among females and among lower socio-economic groups. Socio-economic health inequalities persist, despite the affluence of the welfare state, the high quality of health care and the benefits of social security schemes. Health policy should focus on reducing inequalities in access to health care, in particular to protect the vulnerable groups.

(4) In all member States long waiting lists and waiting times are observed for a range of services. In long-term care problems are reported for home care, geriatric services and nursing homes. In acute hospital care problems are reported for hip fracture surgery or cataract. There is an urgent need to develop and establish clear criteria on how to manage these problems, to guarantee equal access to health care.

(5) To tackle the problem of waiting lists in long-term chronic care alternatives should be developed. In this field promising initiatives were reported, e.g. expansion of day care programmes, reimbursement of family care-givers, involvement of non governmental organisations, reinforcement of volunteer's actions.

(6) Chronic patients should receive comprehensive care, covering all necessary health services, both long term care and acute hospital care. Health authorities should ensure that in the delivery of health care chronic patients have the same rights as other patients. Particular attention should be paid to possible discrimination.

III. Integration

(7) To meet the specific care needs of chronically ill persons a broad spectrum of services should be provided at a local level. The provision of care should be based on the comprehensive needs of individual patients. Extended care facilities at the bottom of the health care pyramid will strengthen the autonomy of the chronically ill.

(8) In looking for strategies to deliver comprehensive integrated care we could distinguish prevention, "cure" and "care", which in the continuum of chronic illness have become inextricably entangled. In many countries public investments are concentrated on acute hospital care. Long-term care-oriented services are under-developed. The challenge for public policy is to redress the balance. The health care needs of chronically ill persons require cure-oriented as well as care-oriented services.

(9,10) Health problems of the chronically ill are strongly interwoven with social problems, e.g. with regard to education, work, social security, housing or income. In many countries health care systems operate separately from social (welfare) systems, at organisational level as well as patient level. High quality health care requires a further intersectoral cooperation.

IV. Continuity and coordination

(11) It is necessary to focus on continuity because chronic care encompasses a wide variety of disciplines and services. The role of general practitioners is well defined in several European countries. General practitioners could ensure the continuity of care.

(12) Chronic care implies a multi-sectoral and multiprofessional collaboration between primary and secondary medical care, between medical and non-medical care and between professional and informal care. To secure continuity of care between the several sectors and to develop networks of care-givers the role of primary care teams should be reinforced.

(13) Reimbursement of care givers is often based on fees for services. Efforts and activities aimed at continuity and coordination of care form no part of the financial system. To ensure that these activities will be integrated in the practice of health care, health policy should envisage financial incentives.

(14) Continuity of care requires a proper interface between home care, hospital care and institutional care. In improving continuity various approaches have been reported: putting a case manager in charge of care for chronic patients or developing shared care packages to smooth the boundaries between the health sectors.

(15) Supporting informal care givers constitutes an inextricable part of the health care for the chronically ill. It includes practical, social and emotional support. The majority of the care for chronic patients is provided by family members, particularly partners of patients. At present, various developments are being reported in this field, e.g. respite care (temporary replacement of informal care in the form of temporary admission to a nursing home or day care).

(16) To assure continuity in the long term it is necessary to develop an adequate system of documentation and registration. On the basis of these data continuity could be monitored and evaluated.

(17) Quality assurance of health care is an increasingly important topic. The assessment of the quality of chronic care is more complicated because of the diversity of involved disciplines and services and the heterogeneity of patient populations. More attention should be paid to establishing indicator systems in assessing the quality of integrated, comprehensive care.

V. Patient Organisations

(18) Patient organisations make an important contribution to both the empowerment of patients and the improvement of health care for the chronically ill. However, patient organisations are not as yet well established in all member States.

(19) The "experience" expertise combined in the patient organisations is essential in adapting health care to the specific needs of the chronically ill. This kind of expertise should be included in public awareness campaigns, educational programmes and research programmes.

(20) Involvement of patients in policy development implies that their organisations are a serious partner in advisory functions and decision making bodies.

VI. Education and Training

(21) Chronically ill diseases have far-reaching consequences for the quality of life of patients. Chronic patients are confronted with complex deficiencies in physical, psychological and social functioning. Public information is necessary to cope adequately with chronic illness.

(22.23) Elaborate efforts are needed to reform theoretical and practical training, in clinical practice and management, to deliver high quality care with well-trained, motivated staff. Continuous training should be aimed at improving therapeutic and supportive skills to cope adequately with the needs of the chronically ill.

(24) To strengthen the required multidisciplinary collaboration the traditionally mono-disciplinary educational programmes should be integrated and made compatible with each other.

(25) Chronically ill childen require a special approach, particularly with regard to their physical and mental development

VII. Research

(26) Research should focus on highly prevalent diseases such as arthrosis, heart diseases, diabetes, stroke, depression or dementia but should encompass also rare diseases.

Epidemiological research is needed on the causes (etiology) and consequences (disease impact) of specific diseases. Special attention should be paid to the phenomenon of multipathology: co-morbidity is a highly prevalent phenomenon among the (elderly) chronically ill.

To get more insight into how to cope successfully we need to unravel chronic disease processes and coping processes.

Research should focus on the distribution of chronic diseases, in particular on health inequalities and on effective interventions to diminish these inequalities. These inequalities are related to age (higher prevalence among elderly), gender (higher prevalence among females), socio-economic status (higher prevalence among lower socio-economic groups).

To deepen the insight into causes and consequences longitudinal studies with a long time horizon are needed.

Most cost-effectiveness studies and most subsidies are directed at innovative programmes, looking for new methods and approaches. To improve the quality of care, research and programmes should also focus on well-established care programmes, the effectiveness and efficiency of which might have been never evaluated.

More knowledge is needed about the efficacy of intervention programmes to cope adequately with chronic illness and to support the chronically ill and their families.

More comparative studies and exchange of results are needed to strengthen high quality care for the chronically ill in member States.

VIII. Implementation

(27) Boards at local, regional or national level are important to channel the development of high quality care and create a forum for debate and exchange of opinions.

A single entry point and information guidance is needed because of the multiplicity of

actors involved in chronically ill care, complicated liaisons and interrelations between different care providers and different levels of services.

It is important to remember that patients and citizens have the right to shape the policies and decide about priorities at the policy development stage, and not only to comment on the implementation of programmes decided in their absence.

APPENDIX V

SPECIFIC TERMS OF REFERENCE

1. Name of the Committee:

2. Type of Committee:

3. Source of Terms of Reference:

4. Terms of Reference:

Transfusion Policy Activities

With the view to shaping European policies, the SP-HM shall:

i. analyse, study and discuss safety, quality and policy aspects of transfusion and the related ethical issues;

ii. analyse the impact of new therapeutic and regulatory developments;

iii. promote safety of transfusion;

iv.    follow the developments in the field of European self-sufficiency, in cooperation with the European Commission and other organisations;

v. assist the new Member States in the restructuring of their blood transfusion services.

To carry out the above, the SP-HM should define a programme of work by identifying a limited number of subjects for short-term study, either by the Bureau of the SP-HM or by consultants. For each subject of study, terms of reference should be drafted, a calendar prepared and an outcome suggested.

Service Activities

vi. Ensure the revision of the guidelines to the Recommendation No(95) 15 on the preparation, use and quality assurance of blood components and of the technical protocol to Agreement 26 on the Exchange of therapeutic substances of human origin.

vii. Ensure availability of rare blood products by means of the European Bank of Frozen Blood of Rare Groups according to Agreement 26 on the Exchange of therapeutic substances of human origin.

 

5. Membership of the Committee :

a. The governments of all member States are entitled to appoint one or two delegate among the experts and the Health authorities responsible for blood transfusion related activities .

The Council of Europe's budget bears travelling and subsistence expenses for one delegate per member State.

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 States, having observer status with the Council of Europe, may send a representative without the right to vote or reimbursement of expenses, to the meetings of the Committee: Canada, United States of America.

d. The following States or organisations may send representatives, without the right to vote or defrayal of expenses, to meetings of the Committee : Australia, WHO, International Society of Blood Transfusion, International Federation of Red Cross and Red Crescent Societies, Order of Malta.

6. Working Structures and Methods :

One plenary meeting of three days every 18 or 24 months in Strasbourg or outside, to be decided by the Bureau and approved by the CDSP.

A Bureau consisting of 10 SP-HM delegates responsible for policy matters should meet twice for two days each year the SP-HM does not meet, and once, for two days and one day before the meeting, in the year the SP-HM meets in order to:

- monitor progress in the implementation of the programme of work,

- deal with urgent questions and take the necessary decisions,

- carry out relevant research work when appropriate,

- decide - on the basis of progress made in the programme of work and of the possible emergence of new developments - on the holding of a plenary SP-HM meeting,

- prepare the relevant agenda, identify the preparatory work needed and possible follow-up.

The Chairman and the members of the Bureau will be elected by the SP-HM at its meetings.

The Bureau will meet in Strasbourg unless the choice of another place can be duly justified.

7. Duration :

These terms of reference expire on 31 December 2000.

APPENDIX VI

SPECIFIC TERMS OF REFERENCE

1. Name of Committee:

2

3. Source of Terms of Reference:

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, giving the justification for the changes made.

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, having observer status with the Council of Europe, may send a representative without the right to vote or reimbursement of expenses, to the meetings of the Committee: Canada, United States of America.

e. The following States or organisations may send representatives, without the right to vote or defrayal of expenses, to the meeting of the Committee: 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 2000.

 

APPENDIX VII

SPECIFIC TERMS OF REFERENCE

1. Name of Committee: Committee of Experts to study organisational aspects of co-operation in organ transplantation (SP-CTO)

2. Type of Committee: Committee of Experts

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

4. Terms of Reference:

The Council of Europe first made proposals on organ transplantation in 1978 in Recommendation R (78) 29 on the Harmonisation of legislations of member States relating to removal, grafting and transplantation of human substances.

This recommendation was followed by a 3rd Conference of European Health Ministers in 1987 on the ethical, organisational and legislative aspects of organ transplantation. The Conference considered that the organisational aspects of organ transplantation were particularly important in meeting the organ shortage and that European co-operation was needed to ensure an efficient organisation.

The Committee of Experts will:

- examine the organisational structures concerning organ transplantation in the member States with a view to detecting the causes of organ shortage;

- study ways of promoting the availability of organs and of improving the organisational infrastructure;

- propose standards for quality assurance of organs and tissues and draw up legal instruments for this purpose;

- develop links between the exchange organisations;

- follow developments in organ transplantation, particularly with regard to their ethical and organisational implications;

- encourage training in organ transplantation, through the organisation of courses and other measures;

- co-operate with the Steering Committee on Bio-Ethics in the preparation of a draft protocol to the Convention on Human Rights and Biomedicine on organ transplantation.

5. Composition of the Committee of experts

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

The Council of Europe's budget will cover travelling and subsistence expenses of one expert from each of the following member States: Austria, Bulgaria, Cyprus, Czech Republic, Germany, Denmark, Lithuania, Netherlands, Norway, Slovakia, Slovenia, Portugal, Spain, United Kingdom.

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 States, having observer status with the Council of Europe, may send a representative without the right to vote or reimbursement of expenses, to the meetings of the Committee: Canada, United States of America.

d. The following States and organisations may send a representative, without the right to vote or defrayal of expenses, to meetings of the Committee: WHO, Eurotransplant, Scandiatransplant.

6. Working structures and methods

7. Duration

These terms of reference expire on 31 December 2000.