Statutory Report 2001 / Last updated 2 January 2002
6. Social Cohesion
Social Cohesion and Policy
Social Security
Family Policy and Children
Migration
Health
Population
Roma
Council of Europe Development Bank (CEB)
Partial Agreement in the Social and Public Health Field
European Department for the Quality of Medicines (EDQM)
Pompidou Group
At their 737th meeting on 17 January (737/6.1a) the Deputies, after taking note of the abridged report of the 5th meeting of the European Committee for Social Cohesion (CDCS), adopted the revised terms of reference of the European Committee for Social Cohesion (CDCS). They also approved the revised terms of reference of the Committee for Coordination in the Social Security Field (CS-CR) and took note of the final activity report on innovatory social policies in the city.
At that meeting (737/6.1b) the Deputies adopted Recommendation Rec(2001)1 of the Committee of Ministers to member states on social workers.
At their 738th meeting on 31 January (738/6.2) the Deputies adopted a reply to Parliamentary Assembly Recommendation 1428 (1999) on the future of senior citizens: protection, participation and promotion. At that same meeting (738/6.4) the Deputies adopted a reply to Congress of Local and Regional Authorities of Europe Recommendation 53 (1999) on policies for deprived children/adolescents and families.
At their 744th meeting on 7 March (744/6.3) the Deputies adopted a reply to Recommendation 52 (1998) on the regions and employment: contribution to social cohesion in Europe of the Congress of Local and Regional Authorities of Europe (CLRAE).
At their 748th meeting on 3 April (748/6.2) the Deputies adopted a reply to Recommendation 62 (1999) of the Congress of Local and Regional Authorities of Europe (CLRAE) on local authorities and employability.
At their 754th meeting on 6, 7 and 8 June (754/6.2) the Deputies took note of the Opinion of the Higher Education and Research Committee (CC-HER) on Parliamentary Assembly Recommendation 1457 (2000) and agreed to communicate it to the Assembly and they adopted the reply to Parliamentary Assembly Recommendation 1457 (2000) on new technologies in small and medium-sized enterprises (SMEs).
At their 759th meeting on 4 July (759/6.1) the Deputies adopted a reply to Parliamentary Assembly Recommendation 1482 (2000) on demographic trends and human potential in the countries of central and eastern Europe.
At that same meeting (759/6.2) the Deputies decided to transmit Parliamentary Assembly Recommendation 1487 (2000) to the European Committee for Social Cohesion (CDCS) for this committee to take it into account when implementing the strategy for social cohesion. They also adopted a reply to Parliamentary Assembly Recommendation 1487 (2000) on the development of a new social system.
At their 759th meeting on 4 July (759/6.3) the Deputies, after examining the abridged report of the 6th meeting of the European Committee for Social Cohesion (CDCS), (Strasbourg, 9-10 May 2001) also approved the revised specific terms of reference for the Forum for Children and Families and approved the specific terms of reference for the Editorial Group for the report on access to social rights.
At the same meeting (759/6.5) the Deputies adopted a reply to Parliamentary Assembly Recommendation 1463 (2000) on a Second World Summit on Social Development.
At their 763rd meeting on 12 September (763/6.1) the Deputies adopted a reply to Parliamentary Assembly Recommendation 1505 (2001) on the amelioration of disadvantaged urban areas in Europe.
At their 768th meeting on 10 October (768/6.2) the Deputies adopted a reply to Recommendation 69 (1999) of the Congress of Local and Regional Authorities of Europe on the Regional economic partnership - a factor for social cohesion, reminding the Congress of the work undertaken on the question within the CDLR.
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As a follow-up to the United Nations General Assembly Special Session on social development (Geneva, 26-30 June 2000), the European Committee for Social Cohesion took part in an "inter-regional reflection on pathways to social development" which was organised in Portugal from 28-30 May 2001 by the Council of Europe's North-South Centre in cooperation with DG III and the Secretariat General of the United Nations.
Social Security
At their 762nd meeting on 5 September (762/1.5) the Deputies took note of the preparations concerning the 8th Conference of European Ministers responsible for Social Security (MSS-8).
At their 776th meeting on 6 December (776/6.1a and b) the Deputies took note of the conclusions of the Committee of Experts on Standard-setting Instruments in the Social Security Field (CS-CO) on the application of the European Code of Social Security and, where relevant, the Protocol thereto by Belgium, Cyprus, Denmark, France, Germany, Greece, Ireland, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, Turkey and the United Kingdom, in accordance with Article 75 of the European Code of Social Security.
They adopted Resolutions ResCSS(2001)1, ResCSS(2001)2, ResCSS(2001)3, ResCSS(2001)4, ResCSS(2001)5, ResCSS(2001)6, ResCSS(2001)7, ResCSS(2001)8, ResCSS(2001)9, ResCSS(2001)10, ResCSS(2001)11, ResCSS(2001)12, ResCSS(2001)13, ResCSS(2001)14, ResCSS(2001)15, ResCSS(2001)16.
At their 738th meeting on 31 January (738/6.1) the Deputies invited their Rapporteur Group on Social and Health Questions (GR-SOC) to prepare, in close co-operation with the Chairs of the Rapporteur Groups GR-H, GR-J and GR-C, a draft political message from the Committee of Ministers for communication to the Special Session of the United Nations General Assembly on Children (originally foreseen to be held in New York on 19-21 September 2001).
The Chairmanship of the Committee of Ministers had proposed that the question be included in the agenda of the 108th Session of the Committee of Ministers (Strasbourg, 10-11 May 2001) and on 11 May, the Ministers adopted a political message on the rights of the child which was to be presented to the General Assembly of the United Nations (CM(2001)71).
At their 750th meeting on 18 April (750/6.3) the Deputies adopted a reply to Parliamentary Assembly Recommendation 1460 (2000) on setting up a European Ombudsman for children.
At their 754th meeting on 6, 7 and 8 June (754/6.3), the Deputies adopted a reply to Parliamentary Assembly Recommendation 1459 (2000) on an Action plan for the children of Kosovo.
At their 766th meeting on 4 October (766/6.2) the Deputies after examining the Report by the Secretary General on the 27th Conference of European Ministers responsible for Family Affairs (Portorož, 20-22 June 2001) (CM(2001)134) decided to transmit it to the European Committee for Social Cohesion (CDCS) so that it could take it into account when planning its future activities, especially those of the Forum for Children and Families. The Deputies also agreed to transmit the report to the Parliamentary Assembly and the Congress of Local and Regional Authorities of Europe (CLRAE) and to the following committees, for information: Steering Committee for Equality between Women and Men (CDEG), Education Committee (CC-ED), European Population Committee (CAHP). Finally, the Deputies instructed the Secretary General to transmit the Final Communiqué of the Conference to the social partners: Union of Industrial and Employers' Confederations of Europe (UNICE) and the European Trade Union Confederation (ETUC), for information.
At their 737th meeting on 17 January (737/6.2) The Deputies adopted a reply to Parliamentary Assembly Recommendation 1449 (2000) on clandestine migration from the south of the Mediterranean into Europe.
At their 744th meeting on 7 March, (744/6.1) the Deputies took note of two opinions submitted to them by the European Committee on Migration (CDMG). One opinion referred to Parliamentary Assembly Recommendation 1467 (2000) on clandestine immigration and the fight against traffickers which they agreed to come back to when all the opinions they had requested would be available. The second opinion referred to Parliamentary Assembly Recommendation 1470 (2000) on the situation of gays and lesbians and their partners in respect of asylum and immigration in the member states of the Council of Europe. A reply to this recommendation was adopted at the same meeting (744/6.4).
At their 752nd meeting on 16 May (752/10.5) the Deputies adopted a reply to Parliamentary Assembly Recommendation 1467 (2000) on clandestine immigration and the fight against traffickers.
At their 754th meeting on 6, 7 and 8 June (754/6.1) the Deputies adopted a reply to Parliamentary Assembly Recommendation 1455 (2000) on the repatriation and integration of the Tatars of Crimea.
At their 762nd meeting held on 5 September (762/6.1), the Deputies decided to prolong the ad hoc terms of reference of the European Health Committee (CDSP) until 31 December 2001 to allow it to complete its examination of Recommendation 1503 (2001) on health conditions of migrants and refugees in Europe.
At their 774th meeting held on 27 November (774/6.1a) the Deputies took note of the opinions on Parliamentary Assembly Recommendations 1489 (2000), 1500 (2001), 1503 (2001) and 1510 (2001) as they appear at Appendix II to CM(2001)161.
They approved the renewal of the terms of reference of the Committees of Experts on the Implementation of the Migration Management Strategy (MG-FL) and on the Legal Status and Other Rights of Immigrants (MG-ST) as they appear respectively at Appendices VII and VIII to CM(2001)161.
They also approved the renewal of the terms of reference of the Committee of Experts on Integration and Community Relations (MG-IN) and the increase of its membership from twenty to twenty three and consequently approved the revised specific terms of reference.
At the same meeting (774/6.1c) the Deputies decided to transmit a draft Recommendation of the Committee of Ministers to member states on the legal status of persons admitted for family reunification to the Steering Committee on Local and Regional Democracy (CDLR) for an opinion and agreed to resume consideration of this item at one of their forthcoming meetings, in the light of the opinion of the CDLR.
Also at the same meeting (774/6.2) the Deputies having taken note of the opinion of the European Committee on Migration (CDMG) on Recommendation 1489(2001) when considering the abridged report of the CDMG's 43rd meeting (CM(2001)161 Appendix II), agreed to communicate the opinion to the Parliamentary Assembly.
At their 778th meeting (778/6.1) the Deputies adopted a reply to Parliamentary Assembly Recommendation 1503 (2001) on Health conditions of migrants and refugees in Europe.
At their 744th meeting on 7 March, (744/6.2a) the Deputies took note of the abridged report of the CDSP's 48th meeting. In this context, they took note, in particular, of the final opinion of the European Health Committee (CDSP) on Recommendation 1445 (2000) of the Parliamentary Assembly on health security for Europe's population, approved the specific terms of reference of a number of committees of experts and the extension of the terms of reference of a further Group of specialists. At that meeting (744/6.2b) the Deputies also adopted Recommendation Rec(2001)4 of the Committee of Ministers to member states on the prevention of the possible transmission of variant Creutzfeldt-Jakob Disease (vCJD) by blood transfusion and Recommendation Rec(2001)5 of the Committee of Ministers to member states on the management of organ transplant waiting lists and waiting times (744/6.2c).
At their 746th meeting on 21 March, (746/6.2) the Deputies took note of the opinions of the Standing Committee of the European Convention on the Protection of Animals kept for Farming Purposes (T-AP) on Parliamentary Assembly Recommendations 1389 (1998) – Consumer safety and food quality, 1417 (1999) – Dioxin crisis and food safety, and 1446 (2000) – Ban on antibiotics in food production, and decided to communicate Parliamentary Assembly Recommendations 1445 (2000) – Health security for Europe's population, and 1446 (2000) – Ban on antibiotics in food production – to the European Commission for information. They also decided to communicate the grouped reply to Parliamentary Assembly Recommendations 1389 (1998), 1417 (1999), and 1445 and 1446 (2000) concerning food safety and consumer protection, adopted at the same meeting, to the European Commission for information.
At their 762nd meeting held on 5 September (762/6.1), the Deputies decided to prolong the ad hoc terms of reference of the European Health Committee (CDSP) until 31 December 2001 to allow it to complete its examination of Recommendation 1503 (2001) on health conditions of migrants and refugees in Europe.
At that same meeting (762/1.5) the Deputies noted that the theme of the 7th European Conference of Health Ministers (12-13 June, 2003 Oslo) would be: “Health, Dignity and Human Rights - the role and responsibility of Health Ministers”.
At their 768th meeting on 10 October (768/6.1a) the Deputies after examining the abridged report of the 49th meeting of the European Health Committee (Strasbourg, 19-20 June 2001), took note of the exchange of letters between Mrs G. Battaini Dragoni, Director General, Social Cohesion, Dr M. Danzon, Regional Director, W.H.O. (Europe), and Mr F. Sauer, Director, Public Health Directorate, European Commission, expressing their commitment to co-operate in the area of health and specifying the areas of co-operation (CM(2001)136, Appendix 2);
They approved the amendments to the specific terms of reference of the following committees:
- Committee of experts on the impact of information technologies on health care – the patient and Internet (SP-IMP/TECH) (CM(2001)136, Appendix 5);
- Committee of experts on reviewing the Revised European Social Charter (Article 11) - policies supporting health protection, health promotion and health care - (SP-PPR) (CM(2001)136, Appendix 6).
The Deputies approved the terms of reference of a Group of specialists on quality assurance for organs, tissues and cells (QA-OTC) (CM(2001)136, Appendix 7).
They also approved the setting up of a Task Force to advise member states at their request on the organisational aspects of organ transplantation.
At that same meeting (768/6.1b) the Deputies adopted Recommendation Rec(2001)12 of the Committee of Ministers to member states on the adaptation of health care services to the demand for health care and health care services of people in marginal situation and took note of the Explanatory Report thereto (CM(2001)136 Addendum 1).
They also (768/6.1c) adopted Recommendation Rec(2001)13 of the Committee of Ministers to member States on developing a methodology for drawing up guidelines on best medical practices and took note of the Explanatory Report thereto (CM(2001)136 Addendum 2).
At their 778th meeting (778/6.1) the Deputies adopted a reply to Parliamentary Assembly Recommendation 1503 (2001) on Health conditions of migrants and refugees in Europe.
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Conferences, seminars, workshops, training courses
- A course to develop professional training for health administrators on the prevention and control of Tuberculosis in Russia was held in Moscow from 27-30 March 2001
- The European Network of Health Promoting Schools (ENHPS) (run jointly by the Council of Europe, the European Union and the WHO Regional Office for Europe) held a "Second workshop on practice of evaluation of the Health Promoting School - models, experiences and perspectives" on 22-24 September 2001 in Nottwil, Switzerland.
- A Workshop on human rights and health promotion and disease prevention took place in Chelyabinsk (Russia) on 7-10 November 2001
- A Task Force Mission to evaluate and assess the progress made in the blood transfusion service took place in Bulgaria on 12-15 November 2001.
- A workshop on developing a national health technology assessment policy took place in Tbilisi, (Georgia) on 12-14 December 2001
Publications 2001
- Guide to the preparation, use and quality assurance of blood components
7th edition
- Pathogen Inactivation of Labile Blood Products
Population
At their 752nd meeting on 16 May (752/6.1) the Deputies, while examining the Abridged report of the 1st meeting of the European Population Committee (CAHP) (Strasbourg, 6-8 February 2001), took note of the programme of activities of the CAHP and approved the holding of a second meeting of the CAHP in 2001, within the limits of available budgetary appropriations for 2001.
At their 759th meeting on 4 July (759/6.1) the Deputies adopted a reply to Parliamentary Assembly Recommendation 1482 (2000) on demographic trends and human potential in the countries of central and eastern Europe.
Roma
At their 774th meeting held on 27 November (774/6.1a) the Deputies agreed to increase the membership of the Group from eleven to thirteen and adopted the revised specific terms of reference.
At that same meeting (774/6.1b) the Deputies adopted Recommendation Rec(2001)17 of the Committee of Ministers to member states on improving the economic and employment situation of Roma/Gypsies and Travellers in Europe.
Council of Europe Development Bank (CEB)
Information on the activities of the Council of Europe Development Bank is available on the internet site: http://www.coebank.org/
At their 745th meeting on 14 March (745/6.1) the Deputies adopted replies to Parliamentary Assembly Recommendations 1447 (2000) on economic consequences of the recent earthquakes in Turkey and Greece, and 1448 (2000) on social consequences of the recent earthquakes in Turkey. These replies mention the financial aid provided by the CEB to the member States concerned, in the form of loans providing for the reconstruction of rural and urban housing units.
At their 759th meeting on 4 July (759/6.5) the Deputies adopted a reply to Parliamentary Assembly Recommendation 1463 (2000) on a Second World Summit on Social Development. This reply mentions the aid provided by the Bank in this field.
At that same meeting (759/6.4) the Deputies took note of the Report for financial year 2000 of the Governor of the Council of Europe Development Bank (CM(2001)83).
Partial Agreement in the Social and Public Health Field
Information on the activities of the Partial Agreement concerning public health and consumer protection is available on the internet site: http://www.coe.fr/soc-sp
At their 742nd meeting on 15 February (742/6.2) the Deputies, in their composition restricted to the Representatives of the member states of the Partial Agreement in the Social and Public Health Field1, adopted Resolution ResAP(2001)1 on the introduction of the principles of universal design into the curricula of all occupations working on the built environment, and forwarded it to the Higher Education and Research Committee (CC-HER), inviting it to contribute to the implementation of the principles enshrined and the measures advocated in this instrument.
At their 746th meeting on 21 March, (746/6.1) the Deputies, in their composition restricted to Representatives of the member states of the Partial Agreement in the Social and Public Health Field, adopted Resolution ResAP(2001) 2 concerning the pharmacist's role in the framework of health security and took note of the opinion of the CD-P-SP on Parliamentary Assembly Recommendations 1445 (2000) on health safety for Europe's population and 1446 (2000) on the ban on antibiotics in food production and in particular of the CD-P-SP's support to the recommendation of the Parliamentary Assembly on the desirability of those member states of the Council of Europe which are not yet members of the Partial Agreement in the social and public health field to accede to it so that they can participate in and benefit from its activities.
At their 766th meeting on 4 October (766/6.1) the Deputies, in their composition restricted to Representatives of the member states of the Partial Agreement in the Social and Public Health Field took note of the abridged report of the 67th Session of the CD-P-SP (CM(2001)125) as a whole and brought it to the attention of the Representatives of the other Council of Europe member states.
At their 770th meeting on 24 October (770/6.1) the Deputies in their composition restricted to the Representatives of the member states of the Partial Agreement in the Social and Public Health Field, after examining the Abridged Report of the 24th session of the Committee on the Rehabilitation and Integration of People with Disabilities (Partial Agreement) (CD-P-RR) held on 26-29 June in the Hague, the Netherlands,
1. adopted Resolution ResAP(2001)3“Towards full citizenship of persons with disabilities through inclusive new technologies”, and took note of the Explanatory Memorandum thereto as set out in Addendum 2 to CM(2001)141;
2. took note of the proposed date, place, general theme and sub-themes of the Second European Conference of Ministers responsible for integration policies for people with disabilities (Malaga, Spain, 7-8 May 2003: “Improving the quality of life of people with disabilities: Enhancing a coherent policy for and through full participation”), which will be prepared by a Committee of Senior Officials and authorised the Secretariat to invite Canada to the latter Committee;
3. took note of the specific terms of reference of the Drafting Group on community living for people with disabilities in need of a high level of support (Partial Agreement)
(P-RR-COLI);
4. took note of the specific terms of reference of the Drafting Group on discrimination against women with disabilities (Partial Agreement) (P-RR-DIWOM);
5. took note of the call for contributions to the 7th edition of the report “Rehabilitation and integration of people with disabilities: policy and legislation”, as a preparatory document for the above-mentioned ministerial conference;
6. brought decisions 2, 3, 4 and 5 above to the attention of the Representatives of the other Council of Europe member states;
7. in the light of decisions 1 to 6 above, took note of the abridged report of the 24th session of the CD-P-RR (CM(2001)141 and Addenda 1 and 2) as a whole;
8. brought the said report to the attention of the Representatives of the other Council of Europe member states.
The Deputies took note of decisions 2, 3, 4 and 5 above.
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- Plants in cosmetics, Volume II, ISBN 92-871-4676-4, Council of Europe, September 2001
- Guidelines concerning scientific substantiation of health-related claims for functional food, 2001
- Report and Guidelines on food and nutritional care in hospitals: how to prevent undernutrition, Provisional edition, 2001
- Cochlear implants in deaf children, 2001
European Forum on food and nutritional care in hospitals: acting together to prevent undernutrition, Strasbourg, 21-22 November 2001.
European Department for the Quality of Medicines (EDQM)2
With regard to the building of the DEQM, see under Section 11 - Administration and Logistics - Accommodation needs.
The areas of responsibility of the European Directorate for the Quality of Medicines are:
- Elaboration of the European Pharmacopoeia and related activities
- European network of Official Medicines Control Laboratories (OMCLs)
Both types of activities are based on partnerships with the European Union to avoid duplication of work. Within this framework, the representatives of the EDQM participated throughout the year in about thirty meetings of the following working parties of the European Agency for the Evaluation of Medicinal Products (EMEA London): Quality Working Party, Biotech Working Party, Immunological Working Party, Inspectors, Herbal Medicinal Products Working Party. In addition, the EDQM also attended the meetings in Brussels of the Pharmaceutical Committee (medicines for human and veterinary use) of the European Commission and the “Notice to Applicants” working party.
Relations with the Commission of the European Communities
A reinforced contract for collaboration with the Commission of the European Communities was signed in November 2000 for 6 years (2000-2005). It provides for the signature every year of an amending clause describing the programme of work decided jointly by the Commission of the European Communities and the EDQM as well as the size of the financial contribution made by the Commission of the European Communities.
This contract covers both the development of a biological standardisation programme for medicinal products and the establishment of an European network of the national control laboratories (see below).
Elaboration of the European Pharmacopoeia and related activities
European Pharmacopoeia Commission
20 to 22 March 2001
69 new or revised monographs and general texts were adopted. 40 chemical reference substances were adopted.
19 to 21 June 2001
During this meeting, 84 new or revised monographs and general texts were adopted, and 49 reference substances were adopted.
20 to 22 November 2001
During this meeting, 112 new and revised monographs and general texts were adopted, and 105 reference substances were adopted.
The steering committee of the biological standardisation programme met on 12 January and 5 July 2001; this meeting was also attended by the Chairs of groups on biologicals for human and veterinary use of the European Pharmacopoeia Commission and the licensing authorities (EMEA) as well as representatives of the Commission of the European Communities and the WHO. The progress made so far was summarised and a programme of activities was organised for the years to come.
The implementation of the contract for biological standardisation signed jointly by the European Community and the Council of Europe, that was initiated in 1992, is actively pursued. Especially noticeable achievements are the distribution of European working standards adopted within the framework of the programme, and the studies being carried out for the validation of an alternative method that could replace the present virulent challenge on animals for several vaccines for human and veterinary use. In this context, scientific symposiums were organised on:
- the pestivirus contamination of bovine sera and its control, (Paris, 29-30 March 2001),
- equine influenza vaccines, 10-11 (Budapest, December 2001).
The half-yearly meetings of the Steering Committee took place on 12 January and 5 July 2001. A programme of activities was adopted for the year to come.
Certification of suitability of monographs of the European Pharmacopoeia
The procedure (resolution AP-CSP (99) 4) was revised to extend its scope to products with risk of transmitting agents of animal spongiform encephalopathies. The first dossiers have been assessed and the first certificates have been granted (gelatin, calf serum for the preparation of vaccines). Owing to the extension of this procedure, the European Pharmacopoeia Commission decided to set up a steering committee. It consists of the Chair of the European Pharmacopoeia Commission, the Chairs of the working parties of the Committee for Proprietary Medicinal Products and the Pharmaceutical Committee of the EMEA and a representative of the Commission of the European Communities.
The procedure continues to grow and it arouses great interest amongst users. In 2001, nearly 215 new dossiers were received on general quality and 220 dossiers were received on the prevention of risk of transmitting spongiform encephalopathy. About 100 new certificates were granted on general quality and 190 on TSE risk.
Conferences, seminars, training sessions
Workshop “Certification for TSE risks products”
Strasbourg (France), 11 January 2001
173 professionals in the area of the quality of medicines from 22 European countries and also from India and the United States, participated in this workshop.
The objectives of the workshop were particularly important:
- reviewing, for the first time, the new extensions of the scope of the procedure to products with a risk of TSE such as gelatin, tallow derivatives, foetal serum, media components and some active ingredients,
- sharing points of view and experience with the principal users,
- and examining the current situation as regards the quality and safety of raw materials used in the pharmaceutical industry to ensure medicines made available are of the highest quality for protection of Public Health.
Conference Current Development in Pharmaceutical analysis
Cannes-Mandelieu (France), 8 – 9 February 2001
268 professionals working in the area of the quality of medicines from 34 European countries and also from Canada, the United States, Malaysia, Israel, Russia and Ukraine who were brought together.
A variety of themes were dealt with:
- the theoretical and practical basis for establishing quality specifications for medicines;
- new techniques now finding a place in pharmaceutical analysis: chromatographic and electrophoretic techniques for enantiomeric purity, near infrared and Raman spectrometry for material analysis;
- in-process testing and parametric release as alternatives to finished product testing;
- future needs for monographs on excipients;
- the place of reference substances and methods for their establishment;
-separation techniques, validation, equipment qualification and performance testing.
Symposium on “Pestivirus Contamination of bovine sera”
Paris (France), 29 – 30 March 2001
This symposium, which is of great importance for future harmonised approach within the framework of VICH, was attended by 108 persons from 17 countries (including Canada, Egypt, United States and Japan).
The current knowledge of pestivirus infection of animals and the potential contamination of materials derived from infected animals, especially bovine sera, as well as the methods to avoid, detect and reduce contamination were critically reviewed.
Regarding preventive measures, it was emphasised that vaccination of animals, especially cattle, prevents spreading of pestivirus infection. The draft European Pharmacopoeia monograph on the vaccine against Bovine Viral Diarrhoea (BVD, caused by one of the strains of pestivirus) was discussed and was seen as an important step towards prevention of BVD infection.
Conference Certification of Suitability of Monographs of the European Pharmacopoeia. New Developments of the Procedure – How to apply for a CEP ?
Athens (Greece), 8 – 9 November 2001
250 professionals in the area of the quality of medicines from 33 countries including Australia, Canada, Egypt, India, China, Israel and the United States, participated in this international conference.
Several ideas for future development had become apparent of which the key issues are:
- adapting the procedure as soon as possible to make the CTD (Common Technical Document adopted by ICH) format acceptable.
- considering the greater use of general monographs, to make possible application for substances not covered by a specific monograph (as done for TSE products).
Symposium “Quality control of equine influenza vaccines?”
Budapest (Hungary), 10 – 11 December 2001
The European Directorate for the Quality of Medicines (EDQM) has organised, in collaboration with the Office International des Epizooties (OIE), this scientific symposium on the quality control of equine influenza vaccines. This symposium brought together 50 representatives from 16 countries (Europe, US, Canada and South Africa), from academia, national and supra-national licensing authorities, vaccine manufacturers and epidemiological/diagnostic centres.
The current epidemiological situation and the licensing requirements in Europe and the Americas as well as the recommendations stipulated by the Office International des Epizooties (OIE) were presented during these two days of exchanges and lively discussions. Issues related to the standardisation and quality control of equine influenza vaccines were critically reviewed and the contribution of the current standards to efficacy and batch consistency of the vaccines were discussed. Finally the future perspectives and challenges in the development and quality control of the vaccines were addressed.
Symposium on Impurities
Strasbourg (France), 19 - 20 December 2001
The symposium gathered 70 representatives of National and European licensing authorities, national control laboratories, Inspection bodies, national pharmacopoeia experts, pharmaceutical industry manufacturers and their suppliers. The aim of the symposium was to assess the needs for the identification and the control of impurities in the world trade context. The conclusions of this symposium will lead to an improvement in the drafting of monographs and to an easier use of the monographs, and thus will improve the protection of consumers.
European network of Official Medicines Control Laboratories (OMCLs)
I. Activities of the plenary network:
These were as follows:
I.1 Annual meeting 24-26 April 2001
The annual plenary meeting of the network was attended by 133 representatives, nearly 50 national laboratories, from 30 European countries.
The following were presented:
- the annual reports of activities of each laboratory.
- the results of tests on marketed medicines for human use and veterinary use (MSS studies) and the implementation of an action plan for 2000. These collaborative studies organised by the EDQM give a real indication of the quality of products on the European pharmaceutical market.
- projects for specialised conferences in the area of new analytical techniques.
- specific guidelines for testing by OMCLs.
I.2 Quality assurance 24 April 2001
The annual plenary meeting of the network as regards quality assurance was held on April 24 and allowed the participants to :
- carry out a review of the current year and a validation of the proficiency testing studies (PTS) programme for the coming year. This validation means that a particular analytical technique and the proficiency of different laboratories can be tested simultaneously on the basis of their results.
- define a harmonised programme to set up a Quality Assurance system in the OMCL network and a specific programme for assistance and maintenance.
- define a programme to train specialised auditors for the network.
I.3 Audits
A programme for audits and intra-laboratory visits was set up to exchange know-how between the various partner laboratories in the network.
Audits of the following sites took place:
- Brussels (Belgium), 26-27 March 2001
- Karlsruhe (Germany), 6-7 November 2001
- Bremen-Schwerin (Germany), 12-16 November 2001
- Paris (France), 3-6 December 2001
- Nicosia (Cyprus), 10-12 December 2001
- Lyon (France), 17-18 December 2001
II. Activities Specific To The European Economic Area
II.1 Batch release activities for biologicals
For the first time the annual meetings for batch release of blood and plasma derivatives and vaccines were held in conjunction with the annual meeting for the OMCL general network. The meeting took place in Uppsala, Sweden 23-27 April 2001. The successful meeting included, in addition to the traditional confidential exchange of information between OMCLs involved in batch release on issues related specifically to batch release, the opportunity to interact with colleagues in a broader context for the mutual exchange of expertise and experience on common issues.
Review of OMCL batch release activities from 2000 for both blood and vaccines and specific scientific presentations highlighted :
- development of methods and procedures to encourage the reduction of animal use for routine batch release activity
- continued use of the communication network, specifically the rapid information system, to exchange information on product related issues, thus improving transparency and the efficient the resolution of common problems.
- evaluation of the need for standardisation of methods and reference preparations through collaborative studies
- effective implementation of Quality assurance systems in the OMCL network to improve mutual confidence amongst members.
Common procedures for batch release of biologicals
Proposed revisions to annexes III and IV of the Administrative Procedure for Batch Release of Biologicals were adopted.
In addition the following 3 new internal procedures were adopted :
- Technical procedure for agreement to reduce in vivo potency testing by OMCLs during batch release
- Procedure for official control authority batch release of centrally authorised immunological medicinal products and medicinal products derived from human blood and plasma
- Procedure for implementation of technical documents for the official control authority batch release network.
Blood products and plasma derivatives
The meeting of the network for batch release of human blood and plasma derivatives took place on 23 April, 2001.
1 new and 3 revised product specific guidelines were adopted. These guidelines can be found in a booklet published by the EDQM and on the EDQM web site.
The meeting of the network for batch release of human vaccines took place on 26-27 April, 2001.
15 new and 17 revised product specific guidelines were adopted. These guidelines can be found in a booklet published by the EDQM and on the EDQM web site.
2 guidelines were approved for consultation
- Meningoccocal C polysaccharide protein conjugate vaccine
- Multivalent pneumococcal polysaccharide conjugate vaccine
Immunological Veterinary Medicinal Products (IVMP)
At a general meeting of OMCLs involved in evaluation of IVMPs, held in Strasbourg on 23 October 2001, the means to improve harmonisation and transparency of the official control authority batch release system in the EU/EEA as implemented according to the current legislation, was discussed. Proposals for action to improve mutual recognition included development of product specific guidelines. A revision of the administrative procedure for OCABR of IVMPs was also undertaken.
Activities for the market surveillance of products with a centralised marketing authorisation
On the basis of a contract signed between the EMEA (European Agency for the Evaluation of Medicinal Products) and the EDQM, a preliminary report of activities was presented at the end of February 2001 on the market surveillance programme (1999-2000) for medicines that have received a centralised authorisation to be commercialised in European Union countries.
The annual meeting of the market surveillance programme for products with a centralised Community marketing authorisation took place on 30 November to discuss problems related to the testing programme for samples taken from the distribution chain for centralised products. The system is based on internal operating procedures that have been elaborated and set up in the network of Official Medicines Control Laboratories. A preliminary summary of the results of the programme for 2001 was presented and the testing programme for 2002 was adopted.
A new clause to the contract with the European Agency for the Evaluation of Medicinal Products (EMEA) was signed in December 2001 to continue the programme for co-operation in 2002.
European Pharmacopoeia 4th Edition
This new edition was published in September 2001. It is available in paper form, on CD-ROM and on-line.
It includes 296 new texts adopted or revised in 2000 as well as texts previously published in the 3rd Edition, for a total of 1606 monographs and 282 general methods of analysis; it replaces the 3rd Edition in its entirety.
This forum is published quarterly. The publication dates were changed in 2000 to January, April, July and October. It presents for public enquiry all the monographs on new substances or revisions of texts that have already been published as well as scientific notes (total of 787 pages for the English edition).
Two special issues of Pharmeuropa Bio presented the results of collaborative studies on biological standardisation.
The proceedings of the before-mentioned conferences were also published
In this context, the European Directorate for the Quality of Medicines participated in the meetings of the Commission of the European Communities in conjunction with the United States and Japan, in order to harmonise the licensing procedures for new medicines for human and veterinary use.
The EDQM participates in the international studies on harmonisation set up by the European Union with the United States and Japan within the framework of the cycle of ICH conferences (International Conference on Harmonisation of licensing dossiers for medicines for human use) and VICH (International Conference on Harmonisation of licensing dossiers for veterinary medicines). At the same time, to support this work, it participates in the Pharmacopoeial Discussion Group with the Pharmacopoeias of the United States and Japan.
The work on the Quality dossier has continued following the ICH4 conference held in July 1997 in Brussels, notably the joint preparation of a guideline on specifications for pharmaceutical substances and preparations which was amended in October 1999. To facilitate the harmonisation of the Pharmacopoeias in this area, the EDQM participated in the following meetings organised with the licensing authorities of the USA, Japan and the European Union (EMEA):
Pharmacopoeial Discussion Group : 21-24 May 2001, Tokyo (Japan)
22-24 October 2001, Strasbourg (France)
Quality Working Party ICH : 21-24 May 2001, Tokyo (Japan)
VICH : 26-27 June 2001
28 May –1 June 2001 Tokyo (Japan)
The EDQM is particularly active in the biological field (vaccines) ; the EDQM had proposed the setting up of a meeting of the relevant working party in Strasbourg in October 2001. This meeting was cancelled due to the international situation following the terrorist attacks on the USA. However, the meeting is expected to be held in 2002.
At their 750th meeting on 18 April (750/6.1) the Deputies, in their composition limited to the Representatives of member states of the Partial Agreement Co-operation Group to Combat Drug Abuse and Illicit Trafficking in Drugs (Pompidou Group)3, took note of the “Report on the modernisation of the Pompidou Group”.
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- Development and improvement of substitution programmes
Proceedings Seminar, Strasbourg, October 2001
- Calculating of the social cost of illicit drugs – Method and tools for estimating the social cost of the use of psychotropic substances by Pierre KOPP
- Contribution to the sensible use of benzodiazepines Proceedings Seminar, Strasbourg, January 2001
- Missing Pieces – Developing drug information systems in Central and Eastern Europe - Technical reports by Michael STAUFFACHER, co-coordinator, September 2001 (joint PG / UNDCP Project: extension of the Multi-city network to Central and Eastern European Europe) [English only]