List of participants
MEMBERS
Prof. J.M. Boeynaems, Prof. J.R. Claude, Dr. W.H. De Jong, Dr. R. Dobbelaer, Prof. M. Giovannini, Dr. J. Löwer, Prof. Dr. H.W.J. Marquardt, Dr.A.H. Pettersen, Prof. P. Preziosi, Dr. E. Rodriguez Farré, Dr. P.Vannier, Prof. D.F. Williams
APOLOGIES
Prof. J.G. Descotes, Dr. K.H. Jones, Prof. J.A. Guimarães Morais, Prof. M. Silbermann, Prof. F. Sjöqvis, Prof. K. Turnheim
COMMISSION
Mme. M. De Solà (DG SANCO), M. A. Lacerda (DG ENTR), M. G. Fracchia (DG SANCO), M. T. Daskaleros ((DG SANCO), Mr. Gouvras (DG SANCO), M. H. Stamm (DG CCR), Dr. A. Sanabria (DG SANCO)
In the absence of Dr. Jones, Prof. D.F. Williams chaired the meeting.
1. Approval of the Agenda
The agenda was adopted as follows:
1- Approval of the agenda.
2- Approval of the Draft Summary Report of the plenary meeting of 16 February.
3- Declarations of Interest.
4- Discussion and possible opinion on the Draft Report on "Toxicological Data on Colouring Agents for Medicinal Products: Silver".
5- Discussion and possible opinion on the Draft Report on "Latex"
6- Information and discussion on the report of the Coordination Group "Harmonisation Risk Assessment".
7- Planning for future action of the Working Group on "Xenotransplantation".
8- Information from the Commission on the Communication "Public Health".
9- Information from the Commission on the STOA Report on "Silicone".
10- Information from the Commission on the Renewal of the Scientific Committees.
11- Other business.
2. Approval of the Draft Summary Report of the plenary meeting of 16 February 2000.
The Draft Summary Report was approved as figures in document SANCO/SCMPMD/2000/0008 Final.
3. Declarations of Interest.
Prof. Williams declared that he had worked in the past on "Silicone" but that he had no current interest in the subject.
No other declarations.
4. Discussion and possible opinion on the Draft Report on "Toxicological Data on Colouring Agents for Medicinal Products: Silver".
A full discussion took place following the explanation of the document by Prof. Preziosi.
The document, after certain modifications, was approved as figures in document SANCO/SCMPMD/2000/0010 Final.
5. Discussion and possible opinion on the Draft Report on "Latex".
The rapporteur, Dr. De Jong, explained the document in detail.
The Committee thanked the rapporteur and the members of the Working Group for the draft report and discussed the document, proposing certain amendments.
The Committee adopted the report and opinion as in document SANCO/SCMPMD/2000/0009 Final, which contains the modifications agreed by the Committee.
6. Information and discussion on the work of the Coordination Group "Harmonisation Risk Assessment".
Dr. Rodriguez-Farré explained the document that will be presented as part of its collaboration with the Working Group of the Steering Committee.
The Committee discussed it and made certain contributions to the document.
The Chairman requested the members to send comments on the document to Dr. Rodriguez-Farré in order to incorporate them in the document. The comments should be sent within the next 10 days.
7. Progress report on the work of the Working Group on "Xenotransplantation".
Dr. De Jong informed the Committee about several documents of the Council of Europe concerning xenotransplantation, and said that he would contact the Chairman of Working Group (WG) of this organisation requesting to be invited as an observer to future meetings of the WG.
Certain members requested that in view of its potential importance this item be added frequently to the agendas of future Committee meetings.
Dr. De Jong said that he would inform the Committee of any news on the matter whenever it appeared.
8. Information from the Commission on the Communication "Public Health".
Mr Gouvras, as representative of DG SANCO G, explained the Communication of the Commission on "Public Health".
The Committee thanked Mr Gouvras for his explanation of the Communication.
9. Information from the Commission on the STOA Report on "Silicone".
M. Lacerda, representative from DG Enterprise, said that the Parliament has discussed at length the STOA Report on "Silicone" and requested the Commission to publish a document on the subject within 6 months.
He also said that several action were announced to the European Parliament by DG Enterprise, such as:
-The elaboration of a document in which the existing essential requirements applicable to silicone breast implants would be specified in more detail and that these requirements will also cover increased monitoring and reporting from manufacturers.
The legal form of this document has still to be decided.
-Provide CEN- Comité Européen de Normalisation- with a specific standardisation mandate, indicating the areas in which European standards or standardisation work should be reinforced.
-Introduce a system of informed patient consent, i.e., provide all relevant information on risks and benefits to the patient and receive consent.
-Continuous R&D, so as to reduce risks on a constant basis and to promote alternatives presenting less risk.
The Chairman thanked Mr Lacerda for his explanation.
10.Information from the Commission on the Renewal of the Scientific Committees.
Mme De Solà, as representative of DG SANCO, thanked the members of the Committee for the work undertaken in the last 3 years. She said that the Committee had adopted 19 opinions of great interest during this period, and summarised each opinion and its importance for the Commission and consumers.
She informed the Committee that a new mandate for a further 3 years was being launched by the Commission, and indicated which topics the renewed Committee would find on the agenda of future meetings.
She also explained on the rules for the selection of the members of the Scientific Committees, because not only was the Scientific Committee on Medicinal Products and Medical Devices being renewed but also the totality of the Scientific Committees of DG SANCO.
The first meeting of the renewed Committee will probably be in November 2000.
11. Other business.
Mme. De Solà informed the Committee on a Draft of a Directive on "Blood", and the implications that this Directive could have for the Committee.
MEMBERS
Prof. J.M. Boeynaems, Prof. J.R. Claude, Dr. W.H. De Jong, Dr. R. Dobbelaer, Prof. M. Giovannini, Dr. J. Löwer, Prof. Dr. H.W.J. Marquardt, Dr.A.H. Pettersen, Prof. P. Preziosi, Dr. E. Rodriguez Farré, Dr. P.Vannier, Prof. D.F. Williams
APOLOGIES
Prof. J.G. Descotes, Dr. K.H. Jones, Prof. J.A. Guimarães Morais, Prof. M. Silbermann, Prof. F. Sjöqvis, Prof. K. Turnheim
COMMISSION
Mme. M. De Solà (DG SANCO), M. A. Lacerda (DG ENTR), M. G. Fracchia (DG SANCO), M. T. Daskaleros ((DG SANCO), Mr. Gouvras (DG SANCO), M. H. Stamm (DG CCR), Dr. A. Sanabria (DG SANCO)
In the absence of Dr. Jones, Prof. D.F. Williams chaired the meeting.
1. Approval of the Agenda
The agenda was adopted as follows:
1- Approval of the agenda.
2- Approval of the Draft Summary Report of the plenary meeting of 16 February.
3- Declarations of Interest.
4- Discussion and possible opinion on the Draft Report on "Toxicological Data on Colouring Agents for Medicinal Products: Silver".
5- Discussion and possible opinion on the Draft Report on "Latex"
6- Information and discussion on the report of the Coordination Group "Harmonisation Risk Assessment".
7- Planning for future action of the Working Group on "Xenotransplantation".
8- Information from the Commission on the Communication "Public Health".
9- Information from the Commission on the STOA Report on "Silicone".
10- Information from the Commission on the Renewal of the Scientific Committees.
11- Other business.
2. Approval of the Draft Summary Report of the plenary meeting of 16 February 2000.
The Draft Summary Report was approved as figures in document SANCO/SCMPMD/2000/0008 Final.
3. Declarations of Interest.
Prof. Williams declared that he had worked in the past on "Silicone" but that he had no current interest in the subject.
No other declarations.
4. Discussion and possible opinion on the Draft Report on "Toxicological Data on Colouring Agents for Medicinal Products: Silver".
A full discussion took place following the explanation of the document by Prof. Preziosi.
The document, after certain modifications, was approved as figures in document SANCO/SCMPMD/2000/0010 Final.
5. Discussion and possible opinion on the Draft Report on "Latex".
The rapporteur, Dr. De Jong, explained the document in detail.
The Committee thanked the rapporteur and the members of the Working Group for the draft report and discussed the document, proposing certain amendments.
The Committee adopted the report and opinion as in document SANCO/SCMPMD/2000/0009 Final, which contains the modifications agreed by the Committee.
6. Information and discussion on the work of the Coordination Group "Harmonisation Risk Assessment".
Dr. Rodriguez-Farré explained the document that will be presented as part of its collaboration with the Working Group of the Steering Committee.
The Committee discussed it and made certain contributions to the document.
The Chairman requested the members to send comments on the document to Dr. Rodriguez-Farré in order to incorporate them in the document. The comments should be sent within the next 10 days.
7. Progress report on the work of the Working Group on "Xenotransplantation".
Dr. De Jong informed the Committee about several documents of the Council of Europe concerning xenotransplantation, and said that he would contact the Chairman of Working Group (WG) of this organisation requesting to be invited as an observer to future meetings of the WG.
Certain members requested that in view of its potential importance this item be added frequently to the agendas of future Committee meetings.
Dr. De Jong said that he would inform the Committee of any news on the matter whenever it appeared.
8. Information from the Commission on the Communication "Public Health".
Mr Gouvras, as representative of DG SANCO G, explained the Communication of the Commission on "Public Health".
The Committee thanked Mr Gouvras for his explanation of the Communication.
9. Information from the Commission on the STOA Report on "Silicone".
M. Lacerda, representative from DG Enterprise, said that the Parliament has discussed at length the STOA Report on "Silicone" and requested the Commission to publish a document on the subject within 6 months.
He also said that several action were announced to the European Parliament by DG Enterprise, such as:
-The elaboration of a document in which the existing essential requirements applicable to silicone breast implants would be specified in more detail and that these requirements will also cover increased monitoring and reporting from manufacturers.
The legal form of this document has still to be decided.
-Provide CEN- Comité Européen de Normalisation- with a specific standardisation mandate, indicating the areas in which European standards or standardisation work should be reinforced.
-Introduce a system of informed patient consent, i.e., provide all relevant information on risks and benefits to the patient and receive consent.
-Continuous R&D, so as to reduce risks on a constant basis and to promote alternatives presenting less risk.
The Chairman thanked Mr Lacerda for his explanation.
10.Information from the Commission on the Renewal of the Scientific Committees.
Mme De Solà, as representative of DG SANCO, thanked the members of the Committee for the work undertaken in the last 3 years. She said that the Committee had adopted 19 opinions of great interest during this period, and summarised each opinion and its importance for the Commission and consumers.
She informed the Committee that a new mandate for a further 3 years was being launched by the Commission, and indicated which topics the renewed Committee would find on the agenda of future meetings.
She also explained on the rules for the selection of the members of the Scientific Committees, because not only was the Scientific Committee on Medicinal Products and Medical Devices being renewed but also the totality of the Scientific Committees of DG SANCO.
The first meeting of the renewed Committee will probably be in November 2000.
11. Other business.
Mme. De Solà informed the Committee on a Draft of a Directive on "Blood", and the implications that this Directive could have for the Committee.