CDBI/INF (2003) 1 rev

Strasbourg, 14 November 2003

Information document concerning the CDBI

(Steering Committee on Bioethics)

INTRODUCTION

Set up in 1949, the Council of Europe is an intergovernmental organisation which fosters political, legal, and cultural cooperation between its 45 member European pluralistic democracies. It is quite distinct from the 15-nation European Union.

The Council of Europe's aims, as specified by its Statute, are to protect human rights and strengthen pluralist democracy, to enhance European cultural identity and seek out solutions to the major problems of our time. The work of the Council of Europe may result in international conventions and in recommendations for CE member States.

The Council of Europe operates through three main bodies, the Committee of Ministers, the Parliamentary Assembly and the Congress of Local and Regional Authorities of Europe. A Secretariat General serves these bodies and is headed by a Secretary General elected for a five-year period. The current Secretary General is Mr Walter Schwimmer (Austria).

The Committee of Ministers comprises the Ministers of Foreign Affairs of the 45 member States. The Ministers' Deputies are the governments' Permanent Representatives to the Council of Europe. They have the same decision-making powers as the Ministers and supervise the Council's activities. They meet at least twice a month. The Deputies set out the Council of Europe's programme of activities and adopt its budget. They also decide what action should be taken on proposals from the Parliamentary Assembly, the Congress of Local Authorities of Europe and from conferences of specialised ministers that the Council of Europe regularly holds. The Committee of Ministers also serves as a permanent forum to discuss European co-operation and common political problems.

Set up under the direct authority of the Committee of Ministers, the Ad hoc Committee of experts on Bioethics (CAHBI) which became in 1992 the Steering Committee on Bioethics (CDBI) has, since 1985, been responsible for the intergovernmental activities of the Council of Europe in the field of bioethics. The work of CAHBI, and then of the CDBI, has led to the adoption of Recommendations of the Committee of Ministers (see Appendix 1) and to the preparation of the Convention on Human Rights and Biomedicine, the first international treaty in this field (adopted by the Committee of Ministers on 19 November 1996; entry into force on 1 December 1999) as well as the additional Protocol on the Prohibition of Cloning Human Beings (adopted by the Committee of Ministers on 6 November 1997; entry into force on 1 March 2001) and the additional Protocol concerning Transplantation of Organs and Tissues of Human Origin (adopted by the Committee of Ministers on 8 November 2001).

I. TERMS OF REFERENCE

1. Name of committee: STEERING COMMITTEE ON BIOETHICS (CDBI)

2. Type of committee: Steering committee

3. Source of terms of reference: Committee of Ministers

4. Terms of reference:

Having regard to the major lines of intergovernmental action set out in the Declaration on the future role of the Council of Europe and Resolution (89) 40, adopted by the Committee of Ministers on 5 May 1989, and within the framework of the annual Intergovernmental Programme of Activities:

i. to study the set of problems posed for law, ethics and human rights by progress in the biomedical sciences, in particular in the light of Parliamentary Assembly Recommendations 934 (1982), 1046 (1986), and 1160 (1991); of the work of the 1st European Ministerial Conference on Human Rights (Vienna, 19-20 March 1985), and of informal meetings of European Ministers of Justice (Edinburgh, 14 June 1985; Ottawa, 17-19 June 1991);

ii. to work with a view to harmonising the policies of member States as far as possible and, if necessary, framing appropriate legal instruments; particularly to prepare additional protocols to the Convention on human rights and biomedicine (ETS N_ 164) on ethical and legal questions related to:

1. organ transplantation
2. medical research
3. protection of the human embryo and foetus
4. human genetics
5. human cloning

iii. having regard to the Secretary General's co-ordinating role, to co-operate with other steering committees and ad hoc committees in the implementation of the Projects involving several fields of activity.

5. Membership of the committee:

a. All member States may designate representatives to the committee. The representatives are chosen from among the following five specialist groups:

- biologists and other scientists;
- medical practitioners;
- lawyers;
- specialists on ethics;
- persons qualified in biomedical questions and able to consider them from a human rights viewpoint.

The Council of Europe's budget bears travelling and subsistence expenses for one representative per member State (two in the case of the State whose expert has been elected Chairman).

b. The presence of a member representing the CDDH and a member representing the CDSP at meetings of the CDBI has been authorised by the Committee of Ministers. The Council of Europe's budget bears travelling and subsistence expenses for one representative of the CDDH and one for the CDSP.

c. The Parliamentary Assembly can also be represented in meetings of the CDBI.

d. The European Commission may participate in meetings of the CDBI.

e. The following may attend the meetings of the Committee, without the right to vote or the defrayal of expenses:

Australia
Canada
Holy See
Israel (3)
Japan
Mexico
United States of America
UNESCO (United Nations Educational, Scientific and Cultural Organization)
OECD (Organization for Economic Co-operation and development)
WHO (World Health Organization)
International Commission on Civil Status
European Science Foundation
KEK (Church and Society Commission of the Conference of European Churches) (1)

6. Working structures and methods:

The CDBI Bureau comprises 9 members (2).

7. Duration:

Renewal by tacit agreement (see Res.(76)3 para 11).

________________________________________________
Adopted: see CM/Del/Concl(92)472/17, Appendix 12
Revised: (1) see CM/Del/Dec(97)602, item 10.5 and Appendix 30
(2) see CM/Del/Dec(98)620, item 10.1, concl. 3
(3) see CM/Del/Dec (2000)727, item 10.1

II. MEMBERSHIP

The governments of the 45 member States¹ may appoint experts. Such members are entitled to vote (1 vote per delegation) on matters arising within the CDBI. Furthermore the Parliamentary Assembly of the Council of Europe and the Commission of the European Communities may appoint representatives.

In addition to the member States, the following countries may send observers: Australia, Canada, Holy See, Israel, Japan, Mexico, United States of America.

The following international organisations may also send observers: UNESCO (United Nations Educational, Scientific and Cultural Organization), OECD (Organization for Economic Co-operation and Development), WHO (World Health Organization), the International Commission on Civil Status, the European Science Foundation, KEK (Church and Society Commission of the Conference of European Churches).

The travelling and subsistence expenses of the experts are reimbursed according to the Council of Europe regulations. Each expert is requested to arrange to travel by the cheapest route and, if possible, make use of reduced transport fares (pex, apex, etc.). Experts are reimbursed upon presentation of documentary evidence of the sum actually paid (invoice, copy of credit card slip, etc...). This evidence of the expenditure must be attached to the claim form for reimbursement together with the relevant travel tickets (plane, train, etc...).

III. BUREAU

In accordance with the provisions of Articles 17 and 18 of the Rules of Procedure for Council of Europe Committees (Resolution (76) 3 on committee structures, terms of reference and working methods) the CDBI elected:
- Ms Dubravka Simonovic (Croatia), Chair (elected in June 2003)
- Prof. Dr. Elmar Doppelfeld (Germany), Vice-Chair (elected in June 2003)
- Mrs Rena Petridou (Cyprus), member of the Bureau (re-elected in December 2002)
- Prof. Boris Yudin (Russian Federation), member of the Bureau (re-elected in December 2002)
- Ms Angela O'Flynn (Ireland), member of the Bureau (re-elected in June 2003)
- Dr Terhi Hermanson (Finland), member of the Bureau (elected in November 2001)
- Dr Givi Javashvili (Georgia), member of the Bureau (elected in December 2002)
- Mrs Isabelle Erny (France), member of the Bureau (elected in December 2002)
- Dr Javier Judez Gutierrez (Spain), member of the Bureau (elected in June 2003)

IV. SECRETARIAT

The Secretariat prepares necessary documentation prior to meetings of the CDBI and its Working Parties, and prepares the meeting reports afterwards. Other duties include assisting in the drafting of documents during the meetings and in the periods between meetings. Utilising its presence at the Council of Europe in Strasbourg, the Secretariat coordinates the flow of information between the CDBI and its Working Parties and other relevant steering committees, working parties, and entities operating at the Council of Europe such as the Committee on Science and Technology, the Social, Health, and Family Affairs Committee, and the Committee on Legal Affairs and Human Rights in the Parliamentary Assembly. Information about other legal instruments currently in force or in the drafting process are provided by the Secretariat. During the meeting, the Secretary General or his/her representative may at any time make an oral or written statement on any subject under discussion (Committee of Ministers Resolution (76) 3, Article 20 b.). Initiation of consensus and compromise within the meetings is one of the main functions of the Secretariat.

V. PARLIAMENTARY ASSEMBLY

The Parliamentary Assembly is the deliberative body of the Council of Europe and is composed of 313 representatives (and the same number of substitutes) appointed by the 45 member States' national parliaments. The Parliamentary Assembly has been represented in the CDBI since 1990 and was asked to give its opinion and propose amendments to drafts of the Convention on Human Rights and Biomedicine. The Recommendations of the Parliamentary Assembly on issues relevant to bioethics over the past 20 years were also taken into account during the drafting of the Convention. The Parliamentary Assembly has asked that each draft Protocol to the Convention be sent to it for an opinion as soon as they are finalised (three Protocols have already been transmitted to it: the Protocol on the Prohibition of Cloning Human Beings, the Protocol concerning Transplantation of Organs and Tissues of Human Origin and the draft Protocol on Biomedical Research).

VI. MEETINGS

The CDBI usually meets twice a year at the headquarters of the Council of Europe in Strasbourg (France). The working languages are English and French. All CDBI documents are in English and French and during the meeting simultaneous interpretation is provided (English-French and vice-versa).

Resolution (76) 3 of the Committee of Ministers (adopted by the Committee of Ministers on 18 February 1976 at the 254th meeting of the Ministers' Deputies) "On Committee Structures, Terms of Reference and Working Methods" sets out the working methods utilised by the CDBI and its Working Parties. While the practice is to try and reach consensus among the experts of the CDBI, Article 14 of the Rules of procedure for Council of Europe Committees (Appendix II of the Resolution) sets out the framework for voting in committees (such as CDBI). It states that each member of the committee shall have one vote and that where a government designates more than one member, only one of them is entitled to take part in the voting. Subject to any contrary provisions in these Rules (Resolution (76) 3), decisions of the steering committees are taken by a two-thirds majority of the votes cast. Procedural matters shall be settled by a majority of the votes cast. Where the question arises as to whether or not a matter is procedural in nature, it may not be so regarded unless the committee decides to that effect by a majority of two thirds of the votes cast. For the purposes of these Rules "votes cast" shall mean the votes of members cast for or against. Members abstaining shall be regarded as not having cast a vote.

VII. WORKING PARTIES

The CDBI is responsible for the following Working Parties:

- Working Party on organ transplantation (CDBI-CO-GT1) responsible for the preparation of a draft Protocol to the Convention on organ transplantation. The finalised draft Protocol was adopted by the CDBI during its 18^th meeting in June 2000; consequently the Working Party no longer meets. The Protocol was opened to signature on 24 January 2002.

- Working Party on biomedical research (CDBI-CO-GT2) responsible for the preparation of a draft Protocol to the Convention on biomedical research.

It is composed as follows: Dr Rosemary Boothman (Ireland), Chair; Dr E. Michael Stormann (Austria); Prof Povl Riis (Denmark); Dr Jean-Marc Laurent-Vo (France); Prof Elmar Doppelfeld (Germany); Dr Joze Trontelj (Slovenia); Prof Zoreslava Shkiryak-Nyzhnyk (Ukraine); Dr David Evered (United Kingdom); Mrs Laurence Cordier (Commission of the European Communities); Mrs Panagiota Dalla-Vorgia (Greece) was a member until her untimely death in February 2002. The finalised draft Protocol was adopted by the CDBI during its 24th meeting in June 2003; consequently, the Working Party no longer meets.

- Working Party on research on stored human biological materials (CDBI-CO-GT2biomat) responsible for the preparation of a draft Instrument on this subject.

It is composed as follows: Prof Elmar Doppelfeld (Germany), Chair; Mr Ants Nomper (Estonia); Mrs Marie Jeanne Mayaux (France); Prof Ismini Kriari-Catranis (Greece); Prof Henriette Roscam Abbing (Netherlands); Mr Pavel Tischenko (Russian Federation); Dr Imogen Evans (United Kingdom).

- Working Party on the protection of the human embryo and foetus (CDBI-CO-GT3) responsible for the activities concerning the protection of the human embryo and foetus.

It is composed as follows: Prof Daniel Serrão (Portugal), Chair; Mrs Sylviane Friart (Belgium); Mrs Sylvia Tomova (Bulgaria); Mr Jean Michaud (France); Prof Ljubov Kurilo (Russian Federation); Dr Miguel Pardo González (Spain); Dr Anne McLaren (United Kingdom); Mrs Line Matthiessen (Commission of the European Communities).

The Working Party elaborated a report on the protection of the human embryo in vitro, which was made public in June 2003.

- Working Party on human genetics (CDBI-CO-GT4) responsible for the preparation of a draft Protocol to the Convention on human genetics.

It is composed as follows:
Core Group:
Mr André Albert (France); Prof Ludger Honnefelder (Germany); Chair: Dr Ruth Reusser (Switzerland)

Experts for applications of genetics for health purposes:
Prof Adriano Bompiani (Italy); Prof Jan Helge Solbakk (Norway); Prof Tadeus Mazurczak (Poland), Prof Vladimir Ivanov (Russian Federation)

Experts for applications of genetics in the field of employment:
Dr Karel Van Damme (Belgium), Dr Helena Kääriäinen (Finland), Prof Alexander McCall Smith (United Kingdom), a representative of the Parliamentary Assembly of the Council of Europe; a representative of the European Commission.

Following a decision of the Committee of Ministers², the CDBI is responsible for the co-ordination of the activities of the Council of Europe aiming at the elaboration of norms or orientations on the ethical, legal and social problems relating to genetics. In order to ensure this cooperation, the Working Party associated experts of the CDBI with other experts from the CDSP (European Health Committee), Prof Henriette Roscam Abbing (Netherlands); and from the CJ-PD (Project Group on data protection), Mr Matthias Horschik (Switzerland).

A Working document presenting a draft first part of the draft Protocol concerning applications for health purposes was made public for comments in February 2003. Work will start on the applications of genetics in the field of employment.

Additional expertise will be required for specific work on application of genetics in the field of insurance. The composition of the Working Party will be modified accordingly.

- Working Party on xenotransplantation (CDBI/CDSP-XENO): under the joint authority of CDBI and European Health Committee (CDSP), responsible for the preparation of guidelines in this field and for making recommendations on public information. The finalised Recommendation on xenotransplantation was approved by the CDBI during its 22^nd meeting in June 2002; consequently the Working Party no longer meets.

Recommendation Rec (2003)10 on xenotransplantation was adopted by the Committee of Ministers on 19 June 2003.

- Working Party on psychiatry and human rights (CDBI-PH), which is responsible for the preparation of guidelines in this field.

The Working Party is composed as follows: Prof David Kingdon (United Kingdom), Chair, named by the CDBI; Mr Frank Schürmann (Switzerland), Vice-Chair, named by the CDCJ (European Committee on Legal Co-operation); Prof Jouko K. Lönnqvist (Finland), named by the CDSP (European Health Committee); Dr Pierre Lamothe (France), named by the CDBI; Prof. Dr Peter Riedesser (Germany), named by the CDBI; Prof E. Roucounas (Greece), named by the CDDH (Steering Committee for Human Rights); Dr Michael Mulcahy (Ireland), named by the CDBI; Mrs Mariavaleria Del Tufo (Italy) named by the CDPC (European Committee on Crime Problems).

- Working Party on biotechnology (CDBI-Biotech): This Working Party was set up in 2000 following the European Conference on ethical and legal questions raised by the developments in biotechnology and their consequences for human beings, animals and the environment. This Working Party was responsible for the preparation of a proposed framework for the future development of draft ethical and legal principles in the field of biotechnology.

These Working Parties are responsible for preparing texts which are then referred to the CDBI for discussion and decision. Except on procedural matters, the Working Parties and the other committees shall not take decisions by voting. They shall state their conclusions in the form of unanimous recommendations, or, if this proves impossible, they shall make a majority recommendation and indicate the dissenting opinions.

VIII. WORK OF THE CDBI

The CDBI has prepared the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Convention on Human Rights and Biomedicine) setting out general principles and rules for the protection of the human being in the context of the development of biology and medicine. The Convention was adopted by the Committee of Ministers on 19 November 1996 and opened for signature on 4 April 1997. The publication of the Explanatory Report to the Convention was authorised by the Committee of Ministers on 17 December 1996. The Convention (ETS No.164) and the Explanatory Report (ref. no. DIR/JUR (97) 5) are available from the Council of Europe Directorate General of Legal Affairs, Bioethics Department.

The CDBI has elaborated a first additional Protocol on the prohibition of cloning human beings. This Protocol was adopted during the 101^st session of the Committee of Ministers, and was opened to signature on 12 January 1998 in Paris.

The second draft Protocol drawn up by the CDBI concerns the transplantation of organs and tissues of human origin. This Protocol was adopted during the 109^th session of the Committee of Ministers, and was opened to signature on 24 January 2002 in Strasbourg.

Protocols on other specific subjects will supplement the Convention. A draft Protocol on Human Genetics is currently being prepared.

The draft additional Protocol on Biomedical Research was approved by the CDBI on 20 June 2003 and forwarded to the Committee of Ministers in September 2003 with a view to its adoption and opening for signature.

A Working Party under the authority of the CDBI prepared a Recommendation on harmonisation of autopsy rules. This Recommendation was adopted by the Committee of Ministers on 2 February 1999. The CDBI also prepared, with the assistance of a Working Party, a Recommendation on xenotransplantation which was adopted by the Committee of Ministers on 19 June 2003.

APPENDIX I

List of Resolutions & Recommendations of the Committee of Ministers in the field of bioethics

1978 Resolution (78) 29 on the harmonisation of legislation of member States relating to removal, grafting and transplantation of human substances

1979 Recommendation R (79) 5 concerning international exchange and transportation of human substances

1981 Recommendation R (81) 1 on regulations for automated medical data banks

1983 Recommendation R (83) 2 on protection of persons suffering from mental disorders placed as involuntary patients

1984 Recommendation R (84) 16 concerning notification of work involving recombinant deoxyribonucleic acid (DNA)

1989 Recommendation R (89)2 on the protection of personal data used for employment purposes

1990 Recommendation R (90) 3 on medical research on human beings

1990 Recommendation R (90) 13 on prenatal genetic screening, prenatal genetic diagnosis and associated genetic counselling

1992 Recommendation R (92) 1 on the use of analysis of deoxyribonucleic acid (DNA) used within the framework of the criminal justice system

1992 Recommendation R (92) 3 on genetic testing and screening for health care purposes

1993 Recommendation R (93) 4 concerning clinical trials involving the use of components and fractionated products derived from human blood or plasma

1994 Recommendation R (94) 1 on human tissue banks

1994 Recommendation R (94) 11 on screening as a tool of preventive medicine

1997 Recommendation R (97) 5 on the protection of medical data

1997 Recommendation R (97) 15 on xenotransplantation

1998 Recommendation R (98) 7 concerning the ethical and organisational aspects of health care in prison

1999 Recommendation R (99) 3 on the harmonisation of medico-legal autopsy rules

1999 Recommendation R (99) 4 on principles concerning the legal protection of incapable adults

2001 Recommendation Rec (2001) 5 on the management of organ transplant waiting lists and waiting times

2002 Recommendation Rec (2002) 9 on the protection of personal data collected and processed for insurance purposes

2003 Recommendation Rec (2003) 10 on xenotransplantation

2003 Recommendation Rec (2003) 12 on organ donor registers

For other bioethical texts of the Council of Europe, including those by the Parliamentary Assembly, please refer to document CDBI/INF (2003) 9, or see the following page of the website of the Bioethics Department:
http://www.coe.int/T/E/Legal_Affairs/Legal_co-operation/Bioethics/Texts_and_documents

APPENDIX II

COUNCIL OF EUROPE
COMMITTEE OF MINISTERS

RESOLUTION (76) 3

ON COMMITTEE STRUCTURES, TERMS OF REFERENCE
AND WORKING METHODS

(adopted by the Committee of Ministers on 18 February 1976
at the 254th meeting of the Ministers' Deputies)

The Committee of Ministers,

Having regard to Resolution (74) 4 on the future role of the Council of Europe;

Having regard to the report of the working party of the Ministers' Deputies set up to study and implement paragraph I.k concerning committee structures, terms of reference and working methods (Doc. CM (75) 156);

Having regard to the report of the working party and of the Secretariat (Doc. CM (75) 309);

In pursuance of Articles 16 and 17 of the Statute,

Resolves as follows:

I. Scope of this resolution

Scope
1. This resolution shall apply to all committees which - whatever their denomination - are composed of persons designated by the governments of member states and set up by the Committee of Ministers, or with its authorization, by virtue of Article 17 of the Council of Europe Statute. The committees set up under the partial agreements under the authority of the Committee of Ministers with its membership restricted to the representatives of member states taking part in the activities covered in the partial agreement in question shall be governed mutatis mutandis by this provision. Sections II to IV below shall not apply to the Conference of Local and Regional Authorities of Europe nor to its subsidiary bodies.

2. Section V of this resolution shall also apply to functions discharged by the Secretary General providing, with the Committee of Ministers' authorization, secretarial services for committees not governed by Article 17 of the Statute, subject to the rules in force for such committees and to such instructions and directives as they, with the Committee of Ministers' explicit agreement, may give the Secretariat in pursuance of such rules³.

3. This resolution shall apply to committees set up under a special statute, having regard to their specific character¹.

II. Committee structures

Types of committees
4. There shall be the following types of committees:

a. steering committee denotes any committee which is answerable directly to the Committee of Ministers and responsible for a substantial portion of the medium-term plan, and to which the governments of all the member states are entitled to designate persons, preferably from among national officials of the highest possible rank;

b. ad hoc committee of experts denotes any committee (other than a steering committee) answerable directly to the Committee of Ministers;

c. committee of experts denotes any committee answerable to a steering committee, whose members all member states are entitled to designate;

d. select committee of experts denotes any committee answerable to a steering committee, whose members only a limited number of member states are entitled to designate;

e. working party denotes any committee composed of a limited number of members of an existing committee designated by that committee.

Observers
5. Any steering committee may, by a unanimous decision, admit or admit to any committee answerable to it, observers from non-member states of the Council of Europe, or from intergovernmental or non-governmental international organisations, provided that:

i. Any request for admission as an observer shall be forwarded without delay by the Secretariat General both to the Permanent Representatives of member states and to the members of the steering committee concerned.

ii. Any government so notified may inform the Secretary General within four weeks of its intention to refer the matter to the Committee of Ministers for decision. This decision shall be taken by a two-thirds majority of all the Representatives entitled to sit on the Committee.

III. Terms of reference

Definition of terms of reference
6. By "terms of reference" shall be understood all directives relating reference to a committee's activities.

Types of terms of reference
7. There shall be the following types of terms of reference:
a. general;
b. specific, viz. :
- sectoral,
- based on the annual programme of activities,
- derived from a convention;
c. ad hoc.

Sources of terms of 8. Terms of reference shall be laid down by the Committee of Ministers,
Reference except in the case of:
a. specific terms of reference given to committees of experts and select committees of experts by the steering committee responsible, in accordance with their general terms of reference;
b. terms of reference derived from a convention;
c. ad hoc terms of reference laid down in accordance with paragraph 20.

General terms of reference
9. The general terms of reference set out in Appendix 1 to this resolution of reference contain the general directives applicable to all committees.

Specific terms of reference
10. Each committee shall have its own terms of reference, which shall reference specify the tasks it is set up to perform. These specific terms of reference thus constitute the instrument setting up the committee.

11. The duration of specific terms of reference shall not exceed the period covered by the medium-term plan. In the case of steering committees they shall be tacitly extended unless otherwise decided.

12. Specific terms of reference may comprise :
a. sectoral terms of reference;
b. one or more sets of terms of reference based on the annual programme of activities;
c. one or more sets of terms of reference derived from a convention;
d. particulars of the qualifications persons invited to become members of the committee should preferably possess;
e. rules governing the repayment of committee members' travelling and subsistence expenses by the Council of Europe.

Sectoral terms of reference
13. In the case of steering committees, specific terms of reference must reference necessarily include sectoral terms of reference describing the section of the medium-term plan for which the committee is responsible and hence the definition of its sphere of competence when carrying out its general terms of reference. If need be, these terms of reference shall indicate any other steering committee(s) engaged in related work.

Terms of reference based on the annual programm of activities
14. For every activity entered in the annual programme of activities, corresponding terms of reference must be mentioned in the programme.

15. In the case of multidisciplinary activities, i.e. those involving more than one committee, the programme shall specify the steering committee mainly responsible.

16. A completion date shall be indicated for each activity.

Terms of reference derived from a convention
17. Terms of reference derived from a convention shall be reproduced in the specific terms of reference given to the committee concerned.

Ad hoc terms of reference
18. The Committee of Ministers may at any time lay down ad hoc terms of reference for any committee.

19. When the Committee of Ministers issues ad hoc terms of reference to a committee of experts or select committee of experts not directly answerable to it, the intermediate committees shall be informed accordingly.

20. Steering committees may, within the limits of their own competence, lay down ad hoc terms of reference for a committee of experts or select committee of experts answerable to them.

21. Ad hoc terms of reference shall include a completion date.

IV. Working methods

Rules of procedure
22. Committee procedure shall be governed by the Rules of Procedure set out in Appendix 2 to this resolution.

V. Role of the Secretariat

General services
23. The Secretary General shall provide committees with the necessary staff, including committee secretaries, as well as with the administrative and other services they may require.

Documentation service
24. The Secretary General shall be responsible for preparing and distributing documents to be discussed by committees.

25. The Secretary General shall in good time inform every committee of the content of its general, specific and any ad hoc terms of reference. He shall also ensure that these texts are available to the committee at all times.

26. a. The Secretariat shall reproduce the reports adopted at committee meetings and circulate them, if possible, within one week.

b. Where a committee is authorised to dispense with a meeting report, the Secretariat shall produce on its own authority a memorandum drawn up in a form as similar as possible to the model meeting report and shall circulate it within the same time-limit.

Drafting of terms of reference
27. When compiling the draft annual programme of activities, the Secretariat shall ensure that terms of reference are included for each activity.

28. The Secretariat shall assist all committees in drafting terms of reference.

Compendium of terms of reference
29. The Secretariat shall compile and keep up to date for restricted circulation a loose-leaf "Compendium of Terms of Reference" containing:

- this Resolution (76)3 and any subsequent amendments to it,
- the general terms of reference,
- the specific terms of reference,
- the ad hoc terms of reference,
- the terms of reference derived from conventions, or special statutes given to committees set up under them,
- the terms of reference of committees of senior officials,
- the decision concerning the admission of observers, case by case,

- Resolution (59)23 of the Committee of Ministers of 16 November 1959 concerning the extension of the activities of the Council of Europe in the social and cultural fields and the decision taken by the Council of WEU on 21 October 1959⁴,
- any other decision of the Committee of Ministers or the Secretary General relating to terms of reference.

Convening of committees
30. The Secretary General shall convene committee meetings in accordance with, in particular, the following rules:

i. Committees shall be convened in accordance with the authorization given by the Committee of Ministers and with the general practices of good management;

ii. Where, in the case of a committee answerable directly to the Committee of Ministers, the Secretary General is of the opinion that a meeting authorised by the latter should not be convened, he shall so inform the Permanent Representatives, explaining his reasons. Where an objection is made by at least two Permanent Representatives within two weeks, the decision shall lie with the Committee of Ministers.

31. All committees shall be convened by the same procedure. Notice of meetings shall be sent to the addresses specified by the member states' Permanent Representatives. It shall specify the name of the committee, the place, date and opening time of the meeting, its probable duration and the subjects to be dealt with. It shall contain an invitation to nominate experts and, in the cases concerned, the indication of the qualifications they should preferably possess. Except on grounds of urgency, which shall be duly explained, notice of meetings shall be circulated at least six weeks before the proposed date.

32. The Secretariat shall circulate to the experts nominated, at least one month before the opening of the meeting, the draft agenda, a provisional list of working papers and the working papers themselves. Any Permanent Representative may ask for copies of the above documents.

33. The Secretary General shall ensure that meetings are so planned that they can be serviced as efficiently and economically as possible.

34. Committees shall be convened at the headquarters of the Council of Europe⁵.

35. Exceptionally, the Secretary General may, if there is no objection from the government of the state on whose territory it is intended to hold the meeting and if suitable technical facilities are available on the spot, convene a committee elsewhere in the case of:

i. very short meetings in places with better rail or air communications than Strasbourg;

ii. meetings where a visit to a specialised establishment in a place other than Strasbourg is essential to the efficiency of the committee's work.

36. For any other departure from the rule in paragraph 34 above, the Secretary General must obtain the prior consent of the Committee of Ministers.

Co-ordination
37. The Secretary General shall ensure that each committee is informed about any activities of other committees which may have implications for the execution of its own terms of reference.

IV. Entry into force of this resolution

Entry into force
38. Sections I and V and Appendix 1 (General terms of reference) shall come into force upon adoption of this resolution.

39. Structures (Section II) and terms of reference other than general terms of reference will be drawn up during 1976 and will replace existing structures and terms of reference not later than 31 December 1976.

40. a. The Rules of Procedure in Appendix 2 shall come into force upon adoption of this resolution, and shall apply to all the committees set up in accordance with this resolution. Existing committees may continue to apply their old rules of procedure in 1976 but these will lapse on 31 December 1976.

b. Clauses of specific rules of procedure which conflict with the Rules of Procedure set out in Appendix 2 shall remain applicable to steering committees taking over the functions of committees which had specific rules of procedure, until 30 June 1977 at the latest.

41. All earlier resolutions and decisions of the Committee of Ministers which concern either committee structures, terms of reference and working methods of committees or instructions given to the Secretariat about its role in relation to committees shall be replaced by this resolution progressively as it becomes applicable, wherever they conflict with it.

APPENDIX 1
to Resolution (76) 3

General terms of reference

Part one

1. To execute, in compliance with the Rules of Procedure:

- the committee's specific terms of reference,
- any ad hoc terms of reference given to the committee.

2.⁶. To ensure that every activity in the annual programme of activities results in :

- the preparation of a draft convention or agreement
and/or
- the preparation of a draft resolution containing recommendations to member governments within the meaning of Article 15.b of the Statute
and/or
- an exchange of views
and always
- the preparation of a final activity report.

3. To set up under the committee, where needed, working parties comprising a limited number of the committee's members, giving them - within the scope of its own terms of reference - precise ad hoc terms of reference of specified duration⁷.

4. To appoint - in the case of all steering committees and as appropriate in the case of ad hoc committees of experts and committees of experts - a bureau whose functions are :

- to assist the Chairman in conducting the committee's business,
- to supervise the preparation of meetings at the committee's request, and
- to ensure continuity between meetings as necessary.

5. To supervise the activities of bodies subordinate to it.

6. To adopt, at the end of each meeting or in exceptional cases as soon as possible thereafter, a meeting report to be addressed to the senior body. Committees other than steering committees may be authorised to dispense with this by the senior body on which they depend,⁸ in which case the latter indicates the period for which such authorization is given.

The meeting report shall contain:

i. a brief foreword (not more than two paragraphs) stating the main subjects dealt with in the report;

ii. a table of contents;

iii. a list of items submitted to the senior body for decision;

iv. a brief summary of the committee's proceedings, clearly indicating any decisions taken and specifying, if need be, majority and minority opinions;

v. appendices comprising :
- a list of participants,
- the agenda of the meeting,
- where appropriate, a preliminary draft agenda for the next meeting,
- the texts submitted for adoption,
- any other relevant texts.

7. To adopt, within the time specified in the terms of reference based on the annual programme of activities or in the ad hoc terms of reference:

- either a final activity report, containing, in particular :

i. a table of contents;

ii. an allusion to the terms of reference based on the annual programme of activities or to the ad hoc terms of reference;

iii. an annotated list of the items submitted to the senior body for decision;

iv. where appropriate, proposals as to the expediency of publishing the report or part thereof;

v. the body of the report ;

vi. the majority and minority opinions should the report, or a part thereof, not reflect the unanimous opinion of the committee;

vii. appendices comprising :
- list of participants,
- any texts submitted for adoption,
- any other relevant text ;

-or, if the terms of reference have not been executed in full within the prescribed time, an interim report indicating the state of progress, the reason for the delay and specific proposals regarding the continuation or cessation of the work.

Part two (steering committees only)

8. To convey to the Secretary General its views on future preliminary draft medium-term plans and on proposals for the biennial review of such plans⁹.

9. To indicate to the Secretary General, for proposal to the Committee of Ministers, activities for inclusion in the annual programme of activities, in the light of the objectives and sub-objectives of the medium-terms plan.

10. a. To set up, as required, for the purpose of preparing and executing particular items in their terms of reference, committees of experts and select committees of experts and lay down their specific terms of reference;

b. To modify, where necessary, the specific terms of reference of such committees within the limits defined by the terms of reference of the steering committee;

c. To decide to instruct the Secretary General, by means of directives, to arrange for the preparation and execution of particular items in their terms of reference, having recourse where appropriate to the services of one or more consultants;

d. Decisions under point a above must be approved by the Committee of Ministers before they can become operative.

11. To devote a part of its meetings to exchanges of views and information on developments, in the field for which it is competent under its sectoral terms of reference, in legislation, policy and administrative practice in each of the member states and on parallel activities in other international organisations.

12. Where a steering committee's specific terms of reference indicate other steering committees engaged in related activities, besides fulfilling the functions specified in paragraph 4 above, the bureau of such a steering committee shall be required to maintain contact with the bureaux of the other steering committees referred to, in order :

- to avoid overlapping and misunderstandings,
- to secure greater cohesion in the Council of Europe's intergovernmental activities, and
- to ensure, in particular, that multidisciplinary activities are carried out as rationally and efficiently as possible.

In the event of difficulties or disagreements, the bureaux shall refer these to the Secretary General. If he cannot resolve them rapidly he shall submit the matter to the Committee of Ministers for decision, informing the members of the steering committees concerned.

APPENDIX 2
to Resolution (76)3

Rules of Procedure for Council of Europe committees

Article 1 - Convocation

Committee meetings shall be convened by the Secretary General in accordance with the instructions of the Committee of Ministers.

Article 2 - Postponement of meetings

When a meeting of a committee has been convened in accordance with the provisions of Article 1, any request for postponement shall be made at least fifteen days before the date fixed for the opening of the meeting; a decision in favour of postponing the meeting shall be regarded as taken if a majority of the members inform the Secretary General of their agreement at least seven days before the date originally fixed.

Article 3 - Agenda

a. The Secretary General shall draw up the draft agenda for a meeting. If the Chairman of the committee has already been appointed, he shall be consulted in advance.

b. The agenda shall be adopted by the committee at the beginning of its meeting.

Article 4 - Documentation

a. Documents for the meeting shall be sent to members by the Secretary General in accordance with the instructions of the Committee of Ministers.

b. Documents requiring a decision, whether originating from the Secretariat or from a member, shall be sent to members at least one month before the opening of the meeting at which the decision is to be taken. In exceptional cases, however, the committee may, if no member objects, consider a document submitted later.

Article 5 - Secrecy of meetings

Committee meetings shall be held in private.

Article 6 - Communications to the press

By unanimous and express agreement of the committee, the Chairman, or the Secretary General on his behalf, may make suitable communications to the press on the work of the committee.

Article 7 - Quorum

There shall be a quorum if two thirds of the members of the committee are present.

Article 8 - Official languages

a. The official languages of the committee shall be those of the Council of Europe.

b. A committee member may speak in a language other than the official languages, in which case he must himself provide for interpretation into one of the official languages.

c. Any document drafted in a language other than the official languages shall be translated into one of the official languages, the member from whom it originates being responsible for making the necessary arrangements.

Article 9 - Observers

a. An observer shall have no right to vote.

b. With the Chairman's permission, an observer may make oral or written statements on the subjects under discussion.

c. Proposals made by observers may be put to the vote if sponsored by a committee member.

Article 10 - Proposals

Any proposal must be submitted in writing if a committee member so requests. In that case it shall not be discussed until it has been circulated.

Article 11 - Order of voting on proposals or amendments

a. Where a number of proposals relate to the same subject, they shall be put to the vote in the order in which they were submitted. In case of doubt, the Chairman shall decide.

b. Where a proposal is the subject of an amendment, the amendment shall be put to the vote first. Where two or more amendments to the same proposal are presented, the committee shall vote first on whichever departs furthest in substance from the original proposal. It shall then vote on the next furthest removed from the original proposal, and so on until all the amendments have been put to the vote. However, where the acceptance of one amendment necessarily entails rejection of another, the latter shall not be put to the vote. The final vote shall then be taken on the proposal as amended or not amended. In case of doubt as to the order of priority, the Chairman shall decide.

c. Parts of a proposal or amendment may be put to the vote separately.

d. In the case of proposals with financial implications, the most costly shall be put to the vote first.

Article 12 - Order of procedural motions

Procedural motions shall take precedence over all other proposals or motions except points of order. They shall be put to the vote in the following order :

a. suspension of the sitting;
b. adjournment of discussion on the item in hand;
c. postponement of a decision on the substance of a proposal until a specified date.

Article 13 - Reconsideration of a question

When a decision has been taken it is only re-examined if a member of the committee so requests, and if this request receives a two-thirds of the votes cast.

Article 14 - Voting

a. Each member of the committee shall have one vote ; however, where a government designates more than one member, only one of them is entitled to take part in the voting.

b. Subject to any contrary provisions in these Rules, decisions of the steering committees are taken by a two-thirds majority of the votes cast.

c. Except on procedural matters, other committees shall not take decisions by voting. They shall state their conclusions in the form of unanimous recommendations, or, if this proves impossible, they shall make a majority recommendation and indicate the dissenting opinions.

d. Procedural matters shall be settled by a majority of the votes cast.

e. Where the question arises as to whether or not a matter is procedural in nature, it may not be so regarded unless the committee decides to that effect by a majority of two thirds of the votes cast.

f. For the purposes of these Rules "votes cast" shall mean the votes of members cast for or against. Members abstaining shall be regarded as not having cast a vote.

Article 15 - Reports

Every committee shall establish the reports specified in its terms of reference.

Article 16 - Minutes

Any committee may, if it considers this necessary, have minutes kept. After meetings, the Secretariat shall submit a draft to the committee members. On expiry of a period specified for the submission of corrections, the Secretariat shall prepare and circulate the final version.

Article 17 - Chair

a. Every committee shall elect a Chairman and Vice-Chairman. However, the Chairman of a committee answerable to a steering committee may be appointed by the latter.

b. The Chairman shall conduct proceedings and sum up the conclusions whenever he thinks necessary. He may call to order a speaker who departs from the subject under discussion or from the committee's terms of reference. He shall retain the right to speak and to vote in his capacity as a member of the committee.

c. The Vice-Chairman shall replace the Chairman if the latter is absent or otherwise unable to take the Chair. If the Vice-Chairman is absent, the Chairman shall be replaced by another member of the bureau, appointed by the latter, or where there is no bureau by a member of the committee appointed by the committee.

d. Election of the Chairman and Vice-Chairman shall require a two-thirds majority at the first ballot and a simple majority at the second ballot. In steering committees, the election shall be held by secret ballot, in other committees by a show of hands, unless a member of the committee requests a secret ballot.

e. Wherever practicable, the Chairman shall be appointed at the end of the meeting preceding expiry of the outgoing Chairman's term of office. Otherwise, he shall be appointed at the beginning of the meeting, in which case the Secretary General or his representative shall take the Chair temporarily.

f. The term of office of the Chairman and Vice-Chairman shall be one year. It may renewed once.

Article 18 - Bureau

a. Every steering committee shall appoint a bureau consisting of the Chairman, the Vice-Chairman and from one to three members of the committee. Any other committee may, if need be, appoint a bureau composed, normally, of three members.

b. Other members of the bureau shall be appointed in the same manner as the Chairman and Vice-Chairman. They shall be appointed immediately after the Chairman and Vice-Chairman in accordance with an equitable geographical distribution.

c. The term of office of such members shall be two years and may be renewed only once. However, a member may, on expiry of his second term, be appointed Chairman. In order to ensure partial replacement of the bureau each year, the first term of one such member shall be limited to one year.

d. A member elected to replace another whose term of office has not expired shall complete his predecessor's term. The same shall apply to the offices of Chairman and Vice-Chairman.

Article 19 - Rapporteur and drafting committee

The committee may appoint a rapporteur, a drafting committee or both.

Article 20 - Secretariat

a. The Secretary General shall provide the committee with the necessary staff, including the committee secretary, as well as with the administrative and other services it may require.

b. The Secretary General or his representative may at any time make an oral or written statement on any subject under discussion.

c. The committee may direct the Secretary General to prepare a report on any question relevant to the committee's work.

d. The Secretariat shall be responsible for preparing and circulating all documents to be examined by the committee.

Article 21 - Revision

Any committee answerable directly to the Committee of Ministers may propose to that Committee either that these Rules be amended, or that certain provisions be added or others waived as far as it or a committee dependent on it is concerned.

APPENDIX III

TERMS OF REFERENCE OF THE WORKING PARTY
ON RESEARCH ON STORED HUMAN BIOLOGICAL MATERIALS
(CDBI-CO-GT2)

1. Name of committee: Working Party on Research on Stored Human Biological Materials
(CDBI-CO-GT2)
2. Type of committee: Working Party
3. Source of terms of reference: Steering Committee on Bioethics (CDBI)
4. Terms of reference¹⁰
a. to examine [ethical and legal] questions related to medical research, in particular research utilising biological materials and personal data; to make proposals (and, where appropriate, alternative proposals) to the CDBI on any question related thereto;
b. to prepare for the CDBI's consideration a draft instrument, relating to medical research utilising biological materials and personal data;
c. to examine and, where appropriate, amend the draft Explanatory Report to be prepared by the Secretariat.
5. Membership:
a. 7 members, to be appointed by the CDBI or its Bureau
The Council of Europe's budget bears travelling and subsistence expenses for the 7 members.
b. The European Commission may participate in meetings of the Working Party as an observer.
6. Working structures and methods:
In order to discharge its functions, the Working Party or its Chair may seek the advice of experts. The experts may, at the request of the Working Party or its Chair, take part in the works of the Working Party.
7. Completion date: December 2004

APPENDIX IV

TERMS OF REFERENCE OF THE WORKING PARTY
ON THE PROTECTION OF THE HUMAN EMBRYO AND FOETUS
(CDBI-CO-GT3)

1. Name of committee: Working Party on the Protection of the Human Embryo and Foetus
(CDBI-CO-GT3)

2. Type of committee: Working Party

3. Source of terms of reference: Steering Committee on Bioethics (CDBI)

4. Terms of reference¹¹

a. to examine [ethical and legal] questions related to the protection of the human embryo and foetus; to elaborate a report on these questions, in particular those related to the protection of the embryo in vitro; to make proposals (and, where appropriate, alternative proposals) to the CDBI on any question related thereto;

b. to prepare for the CDBI's consideration a draft protocol, additional to the Convention on human rights and biomedicine, relating to the protection of the human embryo and foetus;

c to examine and, where appropriate, amend the draft Explanatory Report to be prepared by the Secretariat.

5. Membership:

a. The Council of Europe's budget bears travelling and subsistence expenses for 8 members, appointed by the CDBI.

b. The European Commission may participate in meetings of the Working Party as an observer.

6. Working structures and methods:

In order to discharge its functions, the Working Party or its Chair may seek the advice of experts. The experts may, at the request of the Working Party or its Chair, take part in the works of the Working Party.

7. Completion date: December 2003

APPENDIX V

TERMS OF REFERENCE OF THE WORKING PARTY
ON HUMAN GENETICS
(CDBI-CO-GT4)

1. Name of committee: Working Party on Human Genetics (CDBI-CO-GT4)

2. Type of committee: Working Party

3. Source of terms of reference: Steering Committee on Bioethics (CDBI)

4. Terms of reference:¹²

a. to examine [ethical and legal] questions related to human genetics; to make proposals (and, where appropriate, alternative proposals) to the CDBI on any question related thereto;

b. to prepare for the CDBI's consideration a draft protocol, additional to the Convention on human rights and biomedicine, relating to human genetics;

c. to examine and, where appropriate, amend the draft Explanatory Report to be prepared by the Secretariat.

5. Membership:

a. The Council of Europe's budget bears travelling and subsistence expenses for 8 members, to be appointed by the Bureau of the CDBI:

- 4 permanent members (CDBI members),
- 4 members to be appointed in accordance with subjects to be dealt with.

b. The European Commission may participate in meetings of the Working Party as an observer.

6. Working structures and methods:

In order to discharge its functions, the Working Party or its Chair may seek the advice of experts. The experts may, at the request of the Working Party or its Chair, take part in the works of the Working Party.

7. Completion date: December 2003

APPENDIX VI

TERMS OF REFERENCE OF THE WORKING PARTY
ON PSYCHIATRY AND HUMAN RIGHTS (CDBI-PH)

1. Name of committee: Working Party on Psychiatry and Human Rights (CDBI-PH)¹³

2. Type of committee: Working Party ¹⁴

3. Source of terms of reference: Steering Committee on Bioethics (CDBI) ¹⁵

4. Terms of reference:

Under the authority of the Steering Committee on Bioethics (CDBI) and in the light of Committee of Ministers Recommendation N_ R (83)2 on legal protection of persons suffering from disorder placed as involuntary patients and of Parliamentary Assembly Recommendation 1235 (1994) on psychiatry and human rights, to draw up guidelines to be included in a new legal instrument of the Council of Europe. These guidelines should aim to ensure protection of the human rights and dignity of persons suffering from mental disorder, especially those placed as involuntary patients, including their right to appropriate treatment.

5. Membership:

a. The committee shall be composed of eight specialists designated by the Bureau of the Steering Committee on Bioethics, in consultation with the Chairs of the European Health Committee, the European Committee on Legal Co-operation and the European Committee on Crime Problems. The Council of Europe's budget bears travelling and subsistence expenses for the 8 members.

b. Some intergovernmental or non-governmental organisations may send observers at their own expense and without the right to vote.

6. Working structures and methods:

The CDBI-PH may co-operate (namely through holding joint meetings) with other relevant committees of the Council of Europe in matters of common interest, namely the CDSP, CDCJ, CDPC and CDDH.

In order to discharge its functions, the CDBI-PH or its Chair may seek the advice of external experts. The experts may, at the request of the CDBI-PH or its Chair, take part in the work of the CDBI-PH. It also may have recourse to consultant studies.

In carrying out its terms of reference, the CDBI-PH may organise hearings and written consultations and prepare questionnaires to be sent to member States, non member States and NGOs.

7. Completion date: 31 December 2003