CM(2009)105 8 June 20091
1063 Meeting, 8 July 2009
6 Social cohesion
6.4 European Pharmacopoeia (EDQM)2 –
Consumer Health Protection Committee (CD-P-SC) –
Abridged report of the 1st meeting (Strasbourg, 14-15 May 2009)
Item to be prepared by the GR-SOC at its meeting of 30 June 2009
1. The Consumer Health Protection Committee (CD-P-SC) (Partial Agreement) held its 1st meeting in Strasbourg on 14-15 May 2009. 13 member states of the European Pharmacopoeia were present: Belgium, Croatia, Czech Republic, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Romania, Switzerland and Turkey. Moldova, having recently been granted observer status at the European Pharmacopoeia, also attended the meeting.
2. The following member states had expressed their interest in the work of the CD-P-SC and sent apologies for not being able to attend the present meeting: Austria, Lithuania, Luxembourg, Montenegro, Slovak Republic, Slovenia and the United Kingdom.
3. The European Commission (DG Enterprise and Industry) was present as observer.
4. Dr Susanne Keitel (Director of European Directorate for the Quality of Medicines & HealthCare, EDQM) welcomed the participants and presented the new environment: cosmetics and food packaging materials that were previously hosted by the Partial Agreement in the Social and Public Health Field (16 member states) are now under the aegis of the EDQM. The Department of Biological Standardisation, OMCL Network and HealthCare (DBO), headed by Jean-Marc Spieser, coordinates the Committee work and ensures Secretariat responsibility for these activities since 1 January 2009.
Adoption of the agenda
5. The agenda was adopted (see Appendix).
Election of the Chair and the Vice-Chair
6. In the absence of candidates for the chair and vice-chair, the Committee instructed the Secretariat to chair this session and to defer elections to a forthcoming meeting. The Secretariat informed the Committee that one delegation which could not be present this time, had already expressed its interest in this position.
Communication of decisions of the Committee of Ministers
7. The Secretariat recalled the following decisions by the Ministers’ Deputies, in their composition restricted to representatives of the States Parties to the Convention on the Elaboration of a European Pharmacopoeia3:
i. taking note of the decision to dissolve the Partial Agreement in the Social and Public Health Field as of 1 January 2009 (decision taken on 2 July 2008, see CM/Del/Dec(2008)1031/6.1),
ii. agreeing to the transfer of activities in the fields of cosmetics and food packaging materials to the EDQM as of 1 January 2009 and on the understanding that this would not give rise to an increase in member states’ contributions (see CM/Del/Dec(2008)1031/6.1),
iii. to approve the terms of reference of the new Consumer Health Protection Committee (CD-P-SC) (decision taken on 11 March 2009, see CM/Del/Dec(2009)1050/6.3).
8. The Committee took note of these decisions.
Presentation of the EDQM
9. The EDQM Director presented the Council of Europe, its members, main objectives and bodies. She described the EDQM’s mission which is to contribute to the basic human right of access to good quality medicines and healthcare. She explained its role and responsibilities related to the European Pharmacopoeia and its interaction with national and European authorities and international organisations. She showed the organisational structure of the EDQM Secretariat and presented the EDQM “healthcare” activities. Healthcare comprises activities in the fields of organ transplantation, blood transfusion, pharmaceutical care and as a result of the most recent transfer, also consumer health protection.
10. She said that the EDQM had longstanding experience in the promotion of public health and the elaboration of standards aimed at improving product quality and safety. It provided a well established platform for policy development and co-operation between European member states and stakeholders that will be beneficial for the work in the fields of cosmetics and packaging materials for food and pharmaceutical products. In particular, the network of Official Medicines Control Laboratories (OMCL) could be used as example for sharing work and resources.
11. Several delegations expressed their appreciation for the comprehensive overview and for the timely submission of documents for this meeting.
12. Further questions from delegations dealt with the EDQM interaction with other international and national authorities not only related to medicines, but also to cosmetics and packaging materials, legal implications of the Council of Europe Conventions and Resolutions for the member states and financing of activities relevant to this Committee.
Terms of reference of the CD-P-SC
13. The Secretariat presented the fact sheet stating information on the specific budget as well as the terms of reference of the CD-P-SC and stressed the importance of ensuring continuity in the fields of cosmetics and food packaging materials while identifying common areas of interest with the pharmaceutical sector and shared health concerns.
14. The Secretariat emphasised that the CD-P-SC as Steering Committee worked under the responsibility of the Committee of Ministers to which it will need to report back and provide them with abridged reports on their meetings as well as proposals for Resolutions on specific items, where appropriate.
15. With regard to packaging materials for food and pharmaceutical products, the Secretariat recalled that there had been a discussion at the Committee of Ministers on whether to enlarge the scope of activities to “food contact materials” to include materials in contact with food other than packaging materials (e.g. kitchen ware, cutlery). The present terms of reference reflected the compromise that was found to allow certain activities under the condition of available resources.
16. One delegation pointed out that health risks may arise from both primary and secondary packaging materials and the scope of activities should cover this issue.
17. With regard to the cooperation with other European institutions, the Secretariat reported that an inter-secretariat meeting had been organised between the EDQM and the European Food Safety Authority (EFSA). Prior to drafting the CD-P-SC terms of reference, consideration had been given to any related WHO activities concerning cosmetics or packaging materials for food and pharmaceutical products; however, the Secretariat received the information that there was little interest in these areas.
Discussion and adoption of rules of procedure
18. The Secretariat presented the draft rules of procedure (PA/PH/SC (09)2). Following a detailed discussion of the items addressed in the document, the Committee decided on amendments and instructed the Secretariat to circulate after the end of the meeting amongst all CD-P-SC members the amended version4 for final approval.
Discussion of the work programme 2009
19. The participants held an exchange of view on relevant topics in the two areas, cosmetics and packaging materials. Several delegations referred to activities that had been carried out in the framework of the Partial Agreement in the Social and Public Health Field (see synopsis of activities 2008, CM(2009)14) and indicated the areas where follow-up work could be envisaged:
i. in the field of cosmetics, to pursue the work dealing with safety criteria and requirements for tattoos and permanent make-up as described in Resolution ResAP(2008)1 and to assess safety data for a range of substances that had been previously agreed by the former ad hoc group on tattoos and permanent make-up,
ii. in the field of packaging materials, to pursue the revision of material-specific policy statements and guidelines and to explore the possibilities to set up a network of competent authorities dealing with safety assessment of substances used in such materials based on proposals from the former Committee of Experts on materials in contact with food (P-SC-CDA),
iii. in the fields of cosmetics and packaging materials, to consider the proposals from the former Committee of Experts for future activities and to discuss their feasibility.
20. The representative of the European Commission, Ms Annette Orloff (DG Enterprise and Industry, F3), presented revised EU legislation in the field of cosmetics and highlighted areas where the two institutions could cooperate and be complementary.
21. In the light of the discussion and the information on activities of the European Commission, the Committee agreed in principle to a follow-up work in the indicated areas. It was further agreed that the topics discussed by the delegations with respect to future activities should be further examined on the basis of written proposals from the delegations concerned that take into account general project criteria such as feasibility, participation and resources, complementarity to EU activities, added value and possible outcome for each type of activity.
22. The Committee instructed the Secretariat to present a list of topics that have been suggested by the members present at this meeting, and of relevant project criteria in an annex to the draft terms of reference for the subordinate Expert Committees and to circulate these documents amongst the CD-P-SC members for final approval.
Terms of reference of subordinate bodies for 2009 – P-SC-COS and P-SC-EMB
23. In pursuance of the decisions taken with respect to the work programme, the Committee decided to create the following subordinate bodies and to provide them with terms of reference:
i. Committee of Experts on cosmetic products (P-SC-COS)
ii. Committee of Experts on packaging materials for food and pharmaceutical products (P-SC-EMB)
24. The Secretariat presented the draft terms of reference for each of these Expert Committees (PA/PH/SC (09)3 and PA/PH/SC (09)4). Each Expert Committee shall meet once or twice a year for two days. The terms of reference for these two Committees shall expire on 31 December 2011 which corresponds to the expiry date of the current terms of reference of the CD-P-SC.
25. The Committee decided on amendments and instructed the Secretariat to circulate after the meeting amongst all CD-P-SC members the amended version5 for final approval.
Appointment of experts for the Expert Committees P-SC-COS and P-SC-EMB
26. The Committee instructed the Secretariat to invite member states through their CD-P-SC members, in accordance with the agreed rules of procedure, to appoint national experts for these Committees.
Date of next meetings
27. The CD-P-SC agreed to meet again on 26-27 November 2009 and recommended to the Secretariat to organise meetings of the Expert Committees P-SC-EMB and P-SC-COS in September and October 2009.
1. OPENING OF THE MEETING & WELCOME ADDRESS BY THE DIRECTOR OF THE EDQM
2. PRESENTATION OF THE REPRESENTATIVES OF THE CD-P-SC
3. ELECTION OF THE CHAIR AND THE VICE-CHAIR
- presentation of the candidates
- ballots if needed
4. ADOPTION OF THE AGENDA
5. COMMUNICATION OF DECISIONS OF THE COMMITTEE OF MINISTERS
6. PRESENTATION OF THE EDQM
7. PRESENTATION OF THE TERMS OF REFERENCE
8. DISCUSSION AND ADOPTION OF RULES OF PROCEDURE (PA/PH/SC (09) 2 R)
9. TERMS OF REFERENCE OF SUBORDINATE BODIES FOR 2009
PA/PH/SC (09) 3: terms of reference for the Committee of Experts on packaging materials for food and pharmaceutical products,
PA/PH/SC (09) 4: terms of reference for the Committee of Experts on cosmetic products
10. DISCUSSION OF THE WORK PROGRAMME 2009
Document of interest: PA/PH/SC (09) 6: Synopsis of activities 2008 of the partial agreement in the social and public health field - CM(2009)14
11. ANY OTHER BUSINESS
12. DATE OF NEXT MEETING
Note 1 This document has been classified restricted until examination by the Committee of Ministers.
Note 2 States concerned: Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, “the former Yugoslav Republic of Macedonia”, Turkey and United Kingdom.
Note 3 States concerned: Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, “the former Yugoslav Republic of Macedonia”, Turkey and United Kingdom.
Note 4 The amended version of the document is available at the Secretariat upon request.
Note 5 The amended version of the document is available at the Secretariat upon request.