Committee of Ministers

Comité des Ministres

PUBLIC HEALTH COMMITTEE

62^nd session

Strasbourg, 3 December 1998

REPORT

Distribution

FOR ACTION

- DELEGATIONS AND LIAISON SECTIONS OF THE MEMBER STATES OF THE PARTIAL AGREEMENT PUBLIC HEALTH COMMITTEE (CD-P-SP) (Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, The Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom)

FOR INFORMATION

- Committee of Ministers restricted to Representatives of the member States of the Partial Agreement in the Social and Public Health field: Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, The Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom

 

 

Strasbourg

FOREWORD

At its 62^nd session, the Public Health Committee:

1. was informed that the Representatives, on the Committee of Ministers, of the member States of the Partial Agreement in the Social and Public Health field, at the 645^th meeting held in Strasbourg on 20 October1998:

1.1 had welcomed the accession of Cyprus to this Partial Agreement which took effect on 1 September 1998;

1.2 had noted the amendment made by the CD-P-SP to the terms of reference of its subsidiary bodies, as set out below:

"Duration of terms of reference: Five years, but subject to review at any time.";

1.3 had taken note of the supplementary text of the Public Health Committee to the reply given by the Committee of Ministers to Assembly Recommendation 1289 (1996) on animal welfare and livestock transport in Europe, as set out in Appendix C to the report of the 61^st session of the CD-P-SP;

2. approved the record of the 42^nd session of the Committee of experts on pharmaceutical questions, and in particular:

- the draft resolution on the classification of medicines which are obtainable only on medical prescription (revision of Resolution AP (95) 1);

- the draft resolution on warning phrases for certain categories of medicines (revision of Resolution AP (95) 2);

- the organisation of a seminar on "the pharmacist at the crossroads of new health risks";

3. took note of the record of the 1^st meeting of the multidisciplinary Group on non sport use of banned substances;

4. approved the record of the 34^th session of the Committee of experts on materials coming into contact with food, subject to written comments submitted by delegations before 29 January 1999;

5. approved the record of the 43^rd session of the Committee of experts on flavouring substances, subject to written comments submitted by delegations before 29 January 1999;

6. approved the record of the 30^th session of the Committee of experts on cosmetic products, subject to written comments submitted by delegations before 29 January 1999.

ITEMS SUBMITTED TO THE COMMITTEE OF MINISTERS

The Representatives, on the Committee of Ministers, of the Member States of the Partial Agreement in the Social and Public Health field ^{footnote 1} are invited to :

1. adopt the draft Resolution on the classification of medicines which are obtainable only on medical prescription (revision of Resolution AP (95) 1), as set out in Appendix C to this report;

2. adopt the draft Resolution on warning phrases for certain categories of medicines (revision of Resolution AP (95) 2), as set out in Appendix D to this report;

3. consider the wish expressed as regards the possibility of discussing the draft budget of the Partial Agreement in the Social and Public Health field (item 1 of this report).

TABLE OF CONTENTS

INTRODUCTION

1. ELECTION OF THE CHAIR AND ADOPTION OF THE AGENDA

2. DECISIONS OF THE COMMITTEE OF MINISTERS 8

3. COMMITTEE OF EXPERTS ON PHARMACEUTICAL QUESTIONS

3.1 Draft Resolution on the classification of medicines which are obtainable only on medical prescription (revision of Resolution AP (95) 1)

3.2 Draft Resolution on warning phrases for certain categories of medicines (revision of Resolution AP (95) 2)

3.3 Organisation of a seminar on "the pharmacist at the crossroads of new health risks"

3.4 Multidisciplinary Group on non sport use of banned substances

3.5 Co-operation with the European Union

4. COMMITTEE OF EXPERTS ON NUTRITION, FOOD SAFETY AND CONSUMER HEALTH

5. COMMITTEE OF EXPERTS ON MATERIALS COMING INTO CONTACT WITH FOOD

6. COMMITTEE OF EXPERTS ON FLAVOURING SUBSTANCES

7. COMMITTEE OF EXPERTS ON COSMETIC PRODUCTS

8. OTHER BUSINESS

9. DATE AND PLACE OF THE NEXT SESSION

APPENDIX A         LIST OF PARTICIPANTS

APPENDIX B         PRELIMINARY DRAFT AGENDA FOR THE 63^rd SESSION

APPENDIX C         DRAFT RESOLUTION ON THE CLASSIFICATION OF MEDICINES WHICH ARE OBTAINABLE ONLY ON MEDICAL PRESCRIPTION (REVISION OF RESOLUTION AP (95) 1)

APPENDIX D         DRAFT RESOLUTION ON WARNING PHRASES FOR CERTAIN CATEGORIES OF MEDICINES (REVISION OF RESOLUTION AP (95) 2)

INTRODUCTION

Mrs G. PODESTÀ LE POITTEVIN, Head of the Partial Agreement Division in the Social and Public Health field, opened the 62^nd session of the Partial Agreement Public Health Committee and welcomed delegations on behalf of the Secretary General. She thanked the Committee for its most valuable contribution to the creation of a model health area at European level.

She emphasized that the Committee had been set up as early as 1948, under the Brussels Treaty Organisation and was thus, in some respect, celebrating its 50^th Anniversary; in 1999, it would celebrate its 40^th year of activity within the Council of Europe (Resolution (59) 23 on the extension of the activities of the Council of Europe in the Social and cultural fields). She recalled that Committee of Ministers’ Resolutions (96) 34 and (96) 35 reflected the political will of the member States to strengthen the legal bases of co-operation in the field of health protection of consumers and in that of rehabilitation and integration of persons with disabilities. Indeed, the texts adopted in the former field offered the scientific and methodological basis of legislative reform at national level and of several Community Directives; those adopted in the latter field continued to be a source of inspiration for legislative reform at national level and for several initiatives at the level of the European Union. Moreover, the Parliamentary Assembly of the Council of Europe had recently again paid tribute to the Public Health Committee’s work (Recommendation 1389 of 4 November 1998 on Consumer Safety and Food Quality).

She finally drew the Committee’s attention to the updated list of its publications (P-SG (98) 20) and announced a 1999 Edition of the activity report, covering in particular the years 1997 and 1998.

1. ELECTION OF THE CHAIR AND ADOPTION OF THE AGENDA

On a proposal by Dr. M. MULLER, delegate of Luxembourg, Dr. P. WIUM, delegate of Norway, was elected Chairman.

He welcomed delegations and forwarded to the Committee apologies from the delegations of Cyprus and France and from the representative of the Commission of the European Communities.

The CHAIRMAN invited the Committee to adopt the Agenda, the draft of which was contained in document CD-P-SP (98) 48.

The UNITED KINGDOM delegate expressed the wish that the Agenda should offer the possibility of discussing the draft budget for the following financial year and emphasized the importance of securing a copy of relevant budget documentation on the Partial Agreement in the Social and Public Health field, in order to take an informed view on the proposals and brief the Permanent Representations accordingly.

Whilst understanding this wish, Mrs PODESTÀ LE POITTEVIN observed that, in compliance with texts in force, the examination of the draft budget annually submitted by the Secretary General fell within the sole province of the Committee of Ministers, which discussed and voted it bearing in mind the opinion of the Budget Committee. It did not fall within the prerogatives of a committee - whether operating under a convention or a Partial Agreement, or a steering committee - to express itself on budgetary matters. This would of course not prevent Committee members who so wished from asking their country’s Permanent Representations to give them a copy of the draft Budget. However, such a document would not indicate the actual cost of a Committee’s or a sector’s work, because the activities as such constituted less than 10% of the Partial Agreement Budget, the remaining budgetary allocations covering administrative costs (travelling and subsistence expenses being borne by each government and not by the Partial Agreement Budget).

Conclusions

The Committee asked the Secretariat to transmit this wish to the Committee of Ministers.

2. DECISIONS OF THE COMMITTEE OF MINISTERS

Document:

P-SP-DEC (98) 2 Decisions of the Committee of Ministers concerning the Public Health Committee, taken at the 645^th meeting on 20 October 1998

The Committee was informed that the Representatives, on the Committee of Ministers, of the member States of the Partial Agreement in the Social and Public Health field, at the 645^th meeting held in Strasbourg on 20 October1998:

1. had welcomed the accession of Cyprus to this Partial Agreement which took effect on 1 September 1998;

2. had noted the amendment made by the CD-P-SP to the terms of reference of its subsidiary bodies, as set out below:

"Duration of terms of reference: Five years, but subject to review at any time.";

3. had taken note of the supplementary text of the Public Health Committee to the reply given by the Committee of Ministers to Assembly Recommendation 1289 (1996) on animal welfare and livestock transport in Europe, as set out in Appendix C to the report of the 61^st session of the CD-P-SP.

Conclusions

The Committee took note of document P-SP-DEC (98) 2.

3. COMMITTEE OF EXPERTS ON PHARMACEUTICAL QUESTIONS

Documents:

CD-P-SP (98) 31 Final - Record of the 42^nd session and CD-P-SP (98) 50 and Corringendum - Two draft Resolutions

Mr. Angel RUIZ DE VALBUENA, Secretary of the Committee of experts, presented the record of the 42^nd session of the Committee of experts and informed delegates on progress made in the work programme, which included in particular the following activities:

This activity is mainly carried out by the Committee of Experts on Medicines subject to prescription and includes:

*    the updating of the list of medicines obtainable on prescription only (annual booklet setting out Resolution AP (95) 1 and its appendices, 1998 Edition);

? the revision of Resolutions AP (95) 1 and AP (95) 2 (see below).

- Exchange of information, in particular on: pharmacovigilance, vitamin products, legal importation of unregistered medicines, pharmacists' role in the choice, use, validation and vigilance of medical devices;

- Detailed study of the issue "Prescriptions" (requirements applying to them, problems of validity from one country to another, transmission of prescriptions to the pharmacy);

- Detailed study of "generic medicines";

- Study of the subject "information technologies applying to the provision of pharmaceutical services". A presentation of the potential advantages of these new technologies in the context of the British National Health Service was introduced at the 42^nd session of the Committee of Experts.

Revision of Resolutions AP (95) 1 and AP (95) 2, carried out by the Committee of Experts on Medicines subject to Prescription

3.1 Draft Resolution on the classification of medicines which are obtainable only on medical prescription (revision of Resolution AP (95) 1)

Document:

CD-P-SP (98) 50, and its "Corrigendum"

The Committee reviewed the above draft resolution.

Conclusions

The Committee approved the draft resolution on the classification of medicines which are obtainable only on medical prescription (revision of Resolution AP (95) 1), as set out in Appendix C to this report.

3.2 Draft Resolution on warning phrases for certain categories of medicines (revision of Resolution AP (95) 2)

Document:

CD-P-SP (98) 50, and its "Corrigendum"

The Committee reviewed the above draft resolution.

Conclusions

The Committee approved the draft resolution on warning phrases for certain categories of medicines (revision of Resolution AP (95) 2), as set out in Appendix D to this report.

3.3 Organisation of a seminar on the "pharmacist at the crossroads of new health risks"

Document:

CD-P-SP (98) 31 Final, item 2 and Appendix D

The Secretariat presented the relevant decisions adopted by the ad hoc Organising Committee and by the Committee of experts on pharmaceutical questions:

- the Seminar will be held in Strasbourg from Wednesday 20 to Friday 22 October 1999;

- the main theme of the Seminar will be the value added by the pharmacist to health benefit and cost reduction and, more generally, to the proper use of health resources and the management and mastery of new health risks, with the following title:

"The pharmacist at the crossroads of new health risks"

A preliminary programme for the Seminar (CD-P-SP (98) 31 Final, Appendix D) had been established and invitation letters to Permanent Representations, National Health Authorities, proposed speakers, etc. had been sent out.

Conclusions

The Committee took note of the above-mentioned information.

Conclusions

The Committee approved the record of the 42^nd session of the Committee of experts on pharmaceutical questions (CD-P-SP (98) 31 Final).

3.4 Multidisciplinary Group on non sport use of banned substances

Document:

T-DO (98) 35 - Conclusions of the 1^st meeting

The Committee was informed that the Multidisciplinary Group had expressed its concern concerning this topic, which is a growing challenge for public authorities. It is a challenge to public health, health education and prevention strategies. In the opinion of the Multidisciplinary Group, further action within the framework of the Council of Europe, in the complementary fields of repression, prevention and harm reduction should be taken.

Conclusions

The Committee took note of the above information.

3.5 Co-operation with the European Union

Mr. RUIZ DE VALBUENA informed the Committee on his attendance of the 46^th session of the Pharmaceutical Committee of the Commission of the European Communities.

Conclusions

The Committee congratulated the Committee of Experts on pharmaceutical questions on the way in which it ensured the co-operation with the Commission of the European Communities.

4. COMMITTEE OF EXPERTS ON NUTRITION, FOOD SAFETY AND CONSUMER HEALTH

The Committee noted that the 2^nd session of the Committee of experts on nutrition, food safety and consumer health would take place on 3 and 4 December 1998. The record of the meeting would be submitted for approval at the 63^rd session of the Public Health Committee in July 1999.

Mr. D’ADESKY, Chairman of the Committee of experts on nutrition, food safety and consumer health, informed delegates on the Forum on Functional Food, which was held on 1 to 2 December 1998 in Strasbourg.

He pointed out that more than 130 persons had participated in the Forum.

The aims of the Forum were to:

- provide the platform for governmental and intergovernmental bodies, the Parliamentary Assembly, the scientific community, the food industry and consumer organisations to exchange ideas and interact on functional food;

- enable the Committee of experts on nutrition, food safety and consumer health to provide the national authorities responsible in the member states of the Partial Agreement, as well as the food industry and the consumer, with guidelines on functional food.

The speakers were leading actors on functional food, coming from the scientific community, the food industry, governmental and intergovernmental authorities and consumer organisations.

The Forum concluded that eating a balanced diet should be considered as the main message to the consumer. If supported by sound scientific evidence, functional food, as part of such a diet, could be of additional benefit to the consumer’s health and wellbeing and contribute to reduce disease risk.

A common concept on functional food was needed. In particular a commonly agreed definition of functional foods, clear principles for health claims and bio-markers, supported by sound scientific relevance and validity, should be established.

The Forum recommended to the Committee of experts on nutrition, food safety and consumer health to initiate and support necessary activities aimed at facilitating the establishment of frameworks and guidelines on these issues.

Conclusions

5. COMMITTEE OF EXPERTS ON MATERIALS COMING INTO CONTACT WITH FOOD

Document:

CD-P-SP (98) 45 Record of the 34^th session (English only at the time of the CD-P-SP’s session)

Mr. BAUM, Secretary of the Committee of experts, informed on progress made with the work programme at the 34^th session (23 to 26 November 1998):

Safety evaluation of food contact substances

A new approach with regard to the safety evaluation of food contact substances was under discussion. An ad hoc Group had been set up to elaborate proposals.

Colourants for food contact plastics

Resolution AP (89) 1 on colourants in plastics materials coming into contact with food was under revision.

Paper and board used for food contact products

A draft resolution on paper and board used for food contact products was under discussion. An inventory list was under preparation.

Guidelines for recycled fibres used for food contact products were under preparation by an ad hoc Group.

Test conditions to be set within the specification section of the resolution were under elaboration by an ad hoc Group.

Silicones

The Committee of experts had approved the draft resolution on silicones. The final version of the draft resolution would be submitted for approval to the Committee at its next session.

Packaging inks for indirect food contact

A draft resolution on packaging inks for indirect food contact was under preparation. The resolution would include an inventory list of plasticizers, solvents, driers, pigments and dyes.

Outstanding issues were under discussion by the ad hoc Group on packaging inks.

Metals and alloys

The draft guidelines for metals and alloys in food contact materials would be finalised in 1999.

A drafting Group, in charge of the elaboration of the final version of the draft guidelines had been set up.

Rubber for food contact

A draft resolution on food contact rubber was under preparation.

Surface coatings

Specific topics with regard to Resolution AP (96) 5 on surface coatings concerning the migration limits of monomers and additives set in the inventory list were under discussion. The use of threshold levels, plastic use factors, consumption factors and the conversion of the specific migration limits were under discussion.

Cork

A draft resolution on cork for food contact was under preparation.

Wood

The preparation of guidelines for wood in contact with food had been given low priority.

Conclusions

The Committee approved the record of the 34^th session of the Committee of experts on materials coming into contact with food, subject to written comments submitted by delegations before 29 January 1999.

6. COMMITTEE OF EXPERTS ON FLAVOURING SUBSTANCES

Document:

CD-P-SP (98) 47 - Record of the 43^rd session

Mr. BAUM, Secretary of the Committee of experts, informed on progress made with the work programme at the 43^rd session (12 to 16 October 1998):

Natural sources of flavourings

The Committee of experts was carrying out the toxicological evaluation of more than 650 plants and plant products used by the flavouring industry.

An interim report of about 120 natural sources of flavourings would be published in 1999.

Active principles and other chemical components of natural sources of flavourings

The potential toxicity of more than 35 active principles and other chemical components of natural sources of flavourings were under evaluation.

Plant tissue cultures

The guidelines on plant tissue cultures had been approved by the Committee of experts and had just been published.

Chemically-defined flavouring substances

The re-evaluation of certain chemically-defined flavouring substances of the 4^th edition of the ‘Blue Book’ published in 1992 was currently being carried out.

Conclusions

The Committee approved the record of the 43^rd session of the Committee of experts on flavouring substances, subject to written comments submitted by delegations before 29 January 1999.

7. COMMITTEE OF EXPERTS ON COSMETIC PRODUCTS

Document:

CD-P-SP (98) 33 - Record of the 30^th session

Mr. RUIZ de VALBUENA, Secretary of the Committee of experts, informed the Committee on the results of the 30^th session, which was held from 27 to 30 October 1998.

He informed delegates on progress made in the work programme, which included in particular the following activities:

- Borderline products: the final report would be published next year.

Plant and plant products used as ingredients for cosmetic products: the evaluation of more than 45 plant and plant products was currently being carried out.

- Good manufacturing practices of cosmetic products: a draft Resolution on good manufacturing practices of cosmetic products was under preparation.

- Active principles used in cosmetics: drugs and other active substances used freely as ingredients in products sold as cosmetics on the European market need to be listed and the concentrations need to be limited. An ad hoc Group was working to analyse the lists of these substances.

-        Allergen effects due to cosmetics: a report on the state of the art was under preparation.

- Advertising and claims of cosmetics: a report on the state of the art was under preparation.

Conclusions

The Committee approved the record of the 30^th session of the Committee of experts on cosmetic products, subject to written comments submitted by delegations before 29 January 1999.

8. OTHER BUSINESS

None.

9. DATE AND PLACE OF THE NEXT SESSION

The Committee agreed to hold its 63^rd session on 1^st July 1999 (morning), in conjunction with the CDSP's session.

APPENDIX A

LIST OF PARTICIPANTS

AUSTRIA/AUTRICHE

Mrs V. GREGORICH-SCHEGA

Director

International Relations Department

Federal Ministry of Labour, Health and Social Affairs (VIII/B/9)

Stubenring 1

A-1010 WIEN

Tel 43-1-711 72 - 48 32 or 4718 Fax 43-1-713 86 14

E-mail

BELGIUM/BELGIQUE

M A. D'ADESKY

Conseiller Général

Ministère des Affaires Sociales, de la Santé publique et de l'Environnement

Quartier Esplanade, 11e étage

Cité Administrative

B-1010 BRUXELLES

Tel 32-2-210 48 59 Fax 32-2-210 48 79

E-mail albert.d'[email protected]

CYPRUS/CHYPRE

Excusé/Apologies for absence

DENMARK/DANEMARK

-

FINLAND/FINLANDE

Mrs M-L PARTANEN

Ministerial Adviser

Department for Social and Health Services

Ministry of Social Affairs and Health

P.O. Box 267

FIN-00171 HELSINKI

Tel 358-9-160 43 50 Fax 358-9-160 47 14

E-mail [email protected]

Mr O. SIMONEN

Ministerial Adviser

Department of Prevention and Promotion

Ministry of Social Affairs and Health

P.O. Box 197

FIN-00531 HELSINKI

Tel 358-9-160 43 76 Fax 358-9-160 41 40

E-mail [email protected]

Ms T. MIKKOLA

Senior Adviser

Bureau for International Affairs

Ministry of Social Affairs and Health

P.O. Box 267

FIN-00171 HELSINKI

Tel 358 9 160 88 337 Fax 358 9 160 32 96

E-mail [email protected]

FRANCE

M A. ERNST (Excusé/Apologies for absence)

Chargé de mission pour les Affaires

Européennes - Direction générale de la Santé

Ministère de l'Emploi et de la Solidarité

1 Place de Fontenoy

F-75350 PARIS 07 SP

Tel 33-01 40 56 42 43 Fax 33-01 40 56 40 56

GERMANY/ALLEMAGNE

Mrs M. DROBEK

Federal Ministry for Health

Multilateral Cooperation in the Field of Health

Propsthof 7817

D-53108 BONN

Tel 49-228-941 18 34 Fax 49-228-941 49 12

E-mail [email protected]

IRELAND/IRLANDE

-

ITALY/ITALIE

Dr S. MORICONI

Senior Medical Officer

Head of Section

International Relations and Community Policies

Ministry of Health

Piazzale dell’Industria 20

I-00144 ROME

Tel 39-06 5994, poste 2236 Fax 39-06 5994 2120

E-mail [email protected]

LUXEMBOURG

Dr M. MULLER

Médecin Chef de Division

Division de la Médecine Scolaire

22 rue Goethe

L-1637 LUXEMBOURG

Tel 352-47 85 580 Fax 352-29 61 45

E-mail [email protected]

NETHERLANDS/PAYS-BAS

Drs N.B. Lucas LUYCKX

Ministry of Health, Welfare and Sport

Directorate for Public Health

P.O. Box 20350

NL-2500 EJ DEN HAAG

Tel 31-70 340 68 75 Fax 31-70 340 5554

E-mail [email protected]

NORWAY/NORVEGE

Dr P. WIUM (CHAIRMAN/PRESIDENT)

Chief Medical Adviser

National Board of Health

PO 8128 Dep

N-0032 OSLO

Tel 47-22 24 88 07 Fax 47-22 24 88 68

E-mail

Mr J. R. ESKERUD

Adviser

Department of Hospital Policy

Einar Gerhardsens plass 3 (S-blokka)

P.O. Box 8011 Dep

N-0030 OSLO

Tel 47-22 24 88 48 Fax 47-22 24 83 79

E-mail [email protected]

PORTUGAL

Prof. Vasco Pinto REIS

Direction Generale de la Santé

Av. Alvades Cabaal, 25

P-1200 LISBOA

Tel 351 1 385 8821 Fax 351 1 387 73 82

SPAIN/ESPAGNE

Dr José Juan SANCHEZ SAEZ

Sous-Directeur

Centre National de l’Alimentation

Instituto de Salud "Carlos III"

Ministère de la Santé et de la Consommation

E-28220 MAJADAHONDA

Tel 34-9 1 509 79 14 Fax 34-9 1 509 79 13

E-mail [email protected]

SWEDEN/SUEDE

-

SWITZERLAND/SUISSE

Mme F. GAILLAT ENGELI

Cheffe-suppléante Affaires Internationales

Office fédéral de la Santé publique

CH-3003 BERNE

Tel 41-31-323 24 32 Fax 41-31-324 90 33

E-mail [email protected]

UNITED KINGDOM/ROYAUME-UNI

Mr R. A. KINGHAM

International Branch

Department of Health

Room 545 Richmond House

79 Whitehall

GB-LONDON SW1A 2NS

Tel 44-1-71 210 48 71 Fax 44-1-71 210 57 52

E-mail [email protected]

Mr L. LEVY

International Branch

Department of Health

Room 553 Richmond House

79 Whitehall

GB-LONDON SW1A 2NS

Tel 44-1-71 210 56 83 Fax 44-1-71 210 57 52

E-mail [email protected]

COMMISSION OF THE EUROPEAN COMMUNITIES/ COMMISSION DES COMMUNAUTES EUROPEENNES

Apologies for absence/Excusée

SECRETARIAT

Mrs G. PODESTÀ LE POITTEVIN

Head of the Partial Agreement Division in the Social and Public Health Field

Tel 33-(0)3-88-41 26 10 Fax 33-(0)3-88-41 27 32

E-mail [email protected]

Mr P. BAUM

Principal Administrative Officer

Partial Agreement Division in the Social and Public Health Field

Tel 33-(0)3-88-41 21 76 Fax 33-(0)3-88-41 27 32

E-mail [email protected]

Mr A. L. RUIZ DE VALBUENA

Administrative Officer

Partial Agreement Division in the Social and Public Health Field

Tel 33-0(3)-88-41 21 58 Fax 33-0(3)-88-41 27 32

E-mail [email protected]

Mrs. S. BOULAJOUN

Principal Administrative Assistant

Partial Agreement Division in the Social and Public Health Field

Tel 33-0(3)-88-41 21 75 Fax 33-0(3)-88-41 27 32

E-mail [email protected]

Mrs A. RAMEN

Assistant

Partial Agreement Division in the Social and Public Health Field

Tel 33-(0)3-88-41 33 05 Fax 33-(0)3-88-41 27 32

E-mail [email protected]

INTERPRETERS/INTERPRETES

Mmes

H. PRIACEL

MEYER

Z. IRANI

 

M.

N. EDWARD

APPENDIX B

PRELIMINARY DRAFT AGENDA FOR THE 63^rd SESSION

1.    ADOPTION OF THE AGENDA

2. DECISIONS OF THE COMMITTEE OF MINISTERS

3. COMMITTEE OF EXPERTS ON PHARMACEUTICAL QUESTIONS

4 COMMITTEE OF EXPERTS ON NUTRITION, FOOD SAFETY AND CONSUMER HEALTH

5. COMMITTEE OF EXPERTS ON MATERIALS COMING INTO CONTACT WITH FOOD

6. COMMITTEE OF EXPERTS ON FLAVOURING SUBSTANCES

7. COMMITTEE OF EXPERTS ON COSMETIC PRODUCTS

8. ANY OTHER BUSINESS

9. DATE AND PLACE OF THE NEXT SESSION

APPENDIX C

DRAFT RESOLUTION AP (99) [1]

ON THE CLASSIFICATION OF MEDICINES

WHICH ARE OBTAINABLE ONLY ON MEDICAL PRESCRIPTION

(superseding Resolution AP (95) 1)

(Adopted by the Committee of Ministers on … 1999

at the … meeting of the Ministers' Deputies)

The Representatives, on the Committee of Ministers, of Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom, member states of the Partial Agreement in the Social and Public Health field,

Recalling Resolution (59) 23 of 16 November 1959, concerning the extension of the activities of the Council of Europe in the social and cultural fields;

Having regard to Resolution (96) 35 of 2 October 1996, whereby they revised the structures of the Partial Agreement and resolved to continue, on the basis of revised rules replacing those set out in Resolution (59) 23, the activities hitherto carried out and developed by virtue of that resolution; these being in particular aimed at:

a. raising the level of health protection of consumers in its widest sense, including the making of a constant contribution to harmonising – in the field of products having a direct or indirect impact on the human food chain as well as in the field of pesticides, pharmaceuticals and cosmetics – legislation, regulations and practices governing, on the one hand, quality, efficiency and safety controls for products, and, on the other hand, the safe use of toxic or noxious products;

b. integrating people with disabilities into the community; defining – and contributing to the implementation at European level – of a model of coherent policy for people with disabilities, which takes account simultaneously of the principles of full citizenship and independent living; contributing to the elimination of barriers to people’s integration, whatever their nature, whether psychological, educational, family-related, cultural, social, professional, financial or architectural;

Having regard to the action carried out for several years for the purpose of harmonising their legislation in the public health field and, in particular, in the pharmacy sector;

Considering further that the lack of uniform laws on the supply of medicines restricted to medical prescription has created problems in the field of public health and still raises difficulties at international level;

Considering in particular that the tendency towards auto-medication and over-medication is increasing;

Believing that it is, therefore, increasingly necessary to achieve harmonisation of national laws in this field;

1. Recommend to the governments of the seventeen member states of the Partial Agreement that they restrict to medical prescription the supply of the medicines mentioned in the general provisions set out hereafter;

2. Invite the same governments to accept amendments which may be made later to the appendices  ^{footnote 2} to this resolution by the Public Health Committee (CD-P-SP), which shall carry out an annual revision of these lists in the light of the general provisions set out hereafter.

General provisions

governing the drawing-up and periodical revision

of the list of substances the presence of which in a medicinal product

necessitates the delivery of a medical prescription

1. The only substances affected by the recommended provisions are those used in human medicinal products.

2. Narcotic drugs are not referred to when they are already covered by special common provisions concerning the rules governing their supply.

3. This resolution does not apply to homeopathic preparations or to other similar non-allopathic minute dose preparations on the market in the member states. Sale and supply of these preparations are governed by legal provisions in force in each member state.

4. The lists of substances the presence of which in a medicinal product necessitates the delivery of a medical prescription are drawn up with reference to all the risks, direct or indirect, which they may represent to human health if they are utilised without medical supervision, even in a correct way, or if they are utilised in an incorrect way. In particular, the lists of medicinal products are drawn up according to:

a. their acute and chronic toxicity;

b. clinical experience in use (adverse reactions, tolerance, and so on);

c. their intended actions and uses.

Salts, esters and salts of ester are subject to the same classification as the substances themselves unless otherwise specified in the lists.

In cases where several substances are present in a preparation, the classification should take account of the phenomena of synergy (whether potentiating or not), antagonism or changes in the effects of the components.

5. A medicine may not be supplied except on a medical prescription when one or more of the following conditions apply:

a

. it contains an active principle not previously used for medical purposes and, in particular, a new chemical molecule. In such cases, a revision of any restrictions shall be carried out within a period of not less than three years from the first date of marketing authorisation in one of the member states of the Partial Agreement ;

b. it is used parenterally ^{footnote 3} ;

c

. it contains one or more substances in List I or II ^{footnote 4} in Appendix I hereafter, to which the following criteria apply:

List I

The supply of a medicine containing one of the substances in this list may only be repeated if the prescriber so specifies on the prescription.

List II

The supply of a medicine containing one of the substances in this list may be repeated without the prescribers having so specified, provided that they did not explicitly forbid such repetition and that the amount supplied at renewals (and their frequency) be consistent with the medical and pharmaceutical data (such as the prescribed daily dose, the duration of treatment, the degree of medical supervision required by the condition, and so on).

Exemptions from Lists I and II

For certain substances, exemptions from the "prescription only" requirement may appear in Lists I and II:

- in respect of low dosage or concentration and/or therapeutic indications;

- according to the route of administration and the composition of the medicine;

- according to the total container content.

 

General criteria for classification on the lists

a

- substances intended for conditions calling for short-term treatment and/or for which continuous medical supervision is necessary, either because of potential side-effects or to check the efficacy of treatment;

- substances administered for diagnostic purposes;

- substances with a new pharmacological mechanism of action;

b. List II:

substances intended for conditions for which the patient may continue the regular or intermittent treatment without a new medical advice, and for which well-known side effects do not call for frequent clinical examination.

Preamble to the list of substances

the presence of which in a medicinal product

necessitates the delivery on medical prescription

1. Minimum requirements

The classifications shown are to be considered as minimum requirements; consequently, governments are free to apply stricter rules in any given case.

2. Classification of substances under special study

The substances on which further information is requested, or consultation with interested parties is pending, are marked appropriately.

3. Nomenclature

Wherever possible, the nomenclature used is that of the International Non-Proprietary Names (INN) of the World Health Organization.

4. Revisions

Annual revisions will deal with:

- classification of new substances entering into the composition of medicinal products newly registered in the member states of the Partial Agreement ;

- classification of substances referred to in article 2 of this preamble;

- proposals for adding or deleting substances;

- proposals for adding or deleting derogations;

- proposals for amending exemption conditions.

Proposals for revision will be submitted by 1 January of each year in order to be examined by the competent bodies before 1 July. In cases of urgency, proposals for revision may be submitted at any time.

5. Date of adoption

The published list will indicate in each case the year of adoption by the Partial Agreement Public Health Committee.

APPENDIX D

DRAFT RESOLUTION AP (99) [2]

ON WARNING PHRASES

FOR CERTAIN CATEGORIES OF MEDICINES

(superseding Resolution AP (95) 2)

(Adopted by the Committee of Ministers on … 1999

at the … meeting of the Ministers' Deputies)

The Representatives, on the Committee of Ministers, of Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom, member states of the Partial Agreement in the Social and Public Health field,

Recalling Resolution (59) 23 of 16 November 1959, concerning the extension of the activities of the Council of Europe in the social and cultural fields;

Having regard to Resolution (96) 35 of 2 October 1996, whereby they revised the structures of the Partial Agreement and resolved to continue, on the basis of revised rules replacing those set out in Resolution (59) 23, the activities hitherto carried out and developed by virtue of that resolution; these being in particular aimed at:

a.     raising the level of health protection of consumers in its widest sense, including the making of a constant contribution to harmonising – in the field of products having a direct or indirect impact on the human food chain as well as in the field of pesticides, pharmaceuticals and cosmetics – legislation, regulations and practices governing, on the one hand, quality, efficiency and safety controls for products; and, on the other hand, the safe use of toxic or noxious products;

b.     integrating people with disabilities into the community; definining – and contributing to the implementation at European level – of a model of coherent policy for people with disabilities, which takes account simultaneously of the principles of full citizenship and independent living; contributing to the elimination of barriers to people’s integration, whatever their nature, whether psychological, educational, family-related, cultural, social, professional, financial or architectural;

Having regard to the action carried out for several years for the purpose of harmonising their legislation in the public health field and, in particular, in the pharmacy sector;

Having regard to Resolution AP (94) 1 on the rational use of medicines, adopted by the Committee of Ministers on 10 October 1994 ;

Considering that the misuse of medicines in general constitutes a real danger to public health and that it is in the interest of public health to supply users with clear and comprehensive information on the possible dangers associated with the use of certain categories of medicines;

Considering that the list of warning phrases hereafter recommended should not be considered as complete or final and may at any time be extended to other categories of medicines or revised;

Taking the view that each member state faced with the need to introduce warning phrases for medicines would find harmonisation of such warnings at European level advantageous,

Recommend to the governments of the seventeen member states of the Partial Agreement that the following phrases for the categories of medicines mentioned below be considered as guidelines for the adaptation of relevant national regulations on information concerning medicines.

Notes on the warning phrases: the provisions of this resolution apply primarily to medicines without prescription. However, the warning phrases recommended above may also be used for medicines which are available only on prescription in any case where a member state considers this course appropriate.

The warning phrases are not intended to be reproduced literally in the member states, provided the substance and meaning are reproduced. They are only to be used in those countries where the substance(s) is (are) available in accordance with the law.

Appendix II: Anatomic-therapeutic-chemical (ATC) classification of substances in the alphabectical list in Appendix I.

3     By "parenteral", are intended, in particular, the epidural, extra-amniotic, intra-amniotic, intra-arterial, intra- articular, intravursal, intracardiac, intracavernous, intracervical, intracisternal, intracoronary, intracutaneous, intradiscal, intralymphatic, intramuscular, intraocular, intraperitoneal, intrapleural, intraspinal, intrasternal, intrathecal, intravenous, intra-tracheal, periarticular, perineural, subconjunctival, subcutaneous use.

4    The differentiation in the two lists applies only to the countries which divide prescription medicines into two categories based on whether or not the prescription may be repeated.