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Directorate-General for Health and Food Safety
List of participants
MEMBERS
Prof. J.M. Boeynaems
Dr. W.H. De Jong
Prof. J.G. Descotes
Dr. R. Dobbelaer
Prof. M. Giovannini
Dr. K.H. Jones
Dr. J. Löwer
Prof. Dr. H.W.J. Marquardt
Dr.A.H. Pettersen
Prof. P. Preziosi
Dr. E. Rodriguez Farré
Prof. F. Sjöqvis
Prof. K. Turnheim
Dr. P.Vannier
APOLOGIES
Prof. J.R. Claude
Prof. J.A. Guimarães Morais
Prof. M. Silbermann
Prof. D.F. Williams
COMMISSION
EMEA
M. T. Daskaleros ((DG SANCO)
M. J.Purves
M. A. Lacerda (DG ENTR)
M. G. Fracchia (DG SANCO)
EXPERTS
Mme. M. De Solà (DG SANCO)
Dr. H. Martin (DG SANCO)
Mme. Delaney (DG SANCO)
Dr. A. Sanabria (DG XXIV)
M. H. Stamm (DG CCR)
The Committee expressed their sympathy with Prof. Silberman on the recent death of his mother.
1. Approval of the Agenda
The agenda was adopted as follows:
1- Approval of the agenda. (Doc. SANCO/SCMPMD/2000/0002 Rev.2)
2- Approval of the Draft Summary Report of the plenary meeting of 15 December 1999. (Doc. SANCO/SCMPMD/2000/0001 Rev.1)
3- Declarations of Interest (Annual written declaration).
4- Information from the Commission on the Report "A European Food and Public Health Authority: The future of scientific advice on the EU".
5- Discussion and possible opinion on the Draft Report on "Quality and safety of blood". (Doc. SANCO/SCMPMD/2000/0005)
6- Discussion and possible opinion on the Draft Report on "Update of the Opinion given by the Scientific Committee on Medicinal Products and Medical Devices on the Risk Quantification for CJD Transmission Via Substances of Human Origin".(Doc. SANCO/SCMPMD/2000/0006)
7- Information and discussion on the work of the Coordination Group "Harmonisation Risk Assessment".
8- Progress report on the work of the Working Group on "Xenotransplantation"
9- Progress report on the work of the Working Group on "Latex".
10- Information from the Commission on "Draft Directive amending Council Directive 93/42/EEC concerning medical devices incorporating stable derivatives of human blood or human blood".(Doc. SANCO/SCMPMD/2000/0003)
11- Other business:
Request from Dr.Boeynaems concerning the Opinion of the Committee on "Orphan Drugs" (Doc. SANCO/SCMPMD/2000/0004)
2. Approval of the Draft Summary Report of the plenary meeting of 16 December 1999.
The Draft Summary Report was approved as figures in document SANCO/SCMPMD/2000/0001 Final.
3. Declarations of Interest (Annual written declaration).
Forms for the Declarations of Interest for the year 2000 were distributed among the members of the Committee.
4. Information from the Commission on the Report "A European Food and Public Health Authority: The future of scientific advice on the EU".
A full discussion took place following the explanation of the document by a representative of DG SANCO.
The Chairman thanked the Commission for the information presented.
5. Discussion and possible opinion on the draft report on "Quality and Safety of Blood".
The rapporteur, Prof. Löwer, explained the document in detail, including the content of the annexes.
The Committee thanked the rapporteur and the members of the Working Group for the draft report and discussed the document, with particular emphasis on haemovigilance.
Several members proposed certain modifications on different items and Prof. Löwer redrafted several points of the report in order to take the observations made by the Committee into account.
The Committee adopted the report and opinion as in document SANCO/SCMPMD/2000/0005 Final, which contains the modifications agreed by the Committee.
6. Discussion and possible opinion on the Draft Report on "Update of the Opinion given by the Scientific Committee on Medicinal Products and Medical Devices on the Risk Quantification for CJD Transmission Via Substances of Human Origin".
Prof. Löwer, as rapporteur, explained the document and said that the Opinion given by the Committee on the Risk Quantification for CJD Transmission Via Substances of Human Origin in 1998, had been revised mainly in two points, these concerning "leukodepletion" and "Exclusion of donors at risk for TSE infection by ruminant derived material".
Many members proposed modifications to the document and opinion, and after incorporated these modifications in the draft the Committee adopted the report and opinion as figures in document SANCO/SCMPMD/2000/0006 Final
7. Information and discussion on the work of the Coordination Group "Harmonisation Risk Assessment".
Dr. Rodriguez-Farré explained that they were not many developments on the subject.
He also said that the Working Group will have a final meeting on 18 February in order to draft a document that serve as a contribution from the Scientific Committee on Medicinal Products and Medical Devices to the Working Group of the Scientific Steering Committee dealing with the subject.
He also explained the progress made by the above mentioned WG of the Scientific Steering Committee on the matter.
He also added that a comprehensive report from the WHO on the same subject is available on the Internet.
Chairman requested the rapporteur that a final document on the matter be presented at the next plenary meeting.
8. Progress report on the work of the Working Group on "Xenotransplantation".
The Chairman of the Committee said that the Working Group created to deal with this subject has produced a preliminary report as an information document.
This document is only addressed to the Group and to draw the attention from the Commission on the subject.
Dr. Jones proposed Dr. De Jong as Chairman of the group taking into account that he was unable to continue to chair the group. And also proposed Dr. Vannier as a member of the group because of his the veterinary experience.
The Committee agreed.
9. Progress report on the work of the Working Group on "Latex".
Dr. de Jong said that the Working Group has difficulties to give a response to certain requests, and that will be necessary to have three more meeting before they could draft a report and opinion.
He said that the scientific publications are too divergent, and therefore it is indispensable to reflect carefully before proposing an opinion.
10. Information from the Commission on "Draft Directive amending Council Directive 93/42/EEC concerning medical devices incorporating stable derivatives of human blood or human blood".
M. Lacerda, representative from DG Enterprise, said that the Council adopted a Common Position which, with a Council and Commission's Opinion, will be sent to the European Parliament for the second reading.
Once the legislative process is concluded ,it is expected that the new Directive will cover Medical Devices that incorporates, as integral part, a human blood derivative.
The European Agency for the Evaluation of Medicinal Products (EMEA) will evaluate the quality and safety of the derivative of blood and its scientific opinion must be included in the documentation concerning the device.
The Notified Body may not deliver the certificate (CE Marking of Conformity) if the EMEA's scientific opinion is unfavourable.
The representative of the EMEA explained the common procedure applied by the Agency and the implication on medical devices.
11. Other business.
Request from Dr.Boeynaems concerning the Opinion of the Committee on "Orphan Drugs":
Prof. Boeynaems said that a proposal for a regulation on "Orphan Drugs" has been made by the Commission and that the Opinions given by the Committee on "Clinical Superiority" and "Similarity" are more complete that those which figure in the proposal.
Certain members said that the proposal did not fully take into account the opinions given by the Committee.
Not other points.
MEMBERS
Prof. J.M. Boeynaems
Dr. W.H. De Jong
Prof. J.G. Descotes
Dr. R. Dobbelaer
Prof. M. Giovannini
Dr. K.H. Jones
Dr. J. Löwer
Prof. Dr. H.W.J. Marquardt
Dr.A.H. Pettersen
Prof. P. Preziosi
Dr. E. Rodriguez Farré
Prof. F. Sjöqvis
Prof. K. Turnheim
Dr. P.Vannier
APOLOGIES
Prof. J.R. Claude
Prof. J.A. Guimarães Morais
Prof. M. Silbermann
Prof. D.F. Williams
COMMISSION
EMEA
M. T. Daskaleros ((DG SANCO)
M. J.Purves
M. A. Lacerda (DG ENTR)
M. G. Fracchia (DG SANCO)
EXPERTS
Mme. M. De Solà (DG SANCO)
Dr. H. Martin (DG SANCO)
Mme. Delaney (DG SANCO)
Dr. A. Sanabria (DG XXIV)
M. H. Stamm (DG CCR)
The Committee expressed their sympathy with Prof. Silberman on the recent death of his mother.
1. Approval of the Agenda
The agenda was adopted as follows:
1- Approval of the agenda. (Doc. SANCO/SCMPMD/2000/0002 Rev.2)
2- Approval of the Draft Summary Report of the plenary meeting of 15 December 1999. (Doc. SANCO/SCMPMD/2000/0001 Rev.1)
3- Declarations of Interest (Annual written declaration).
4- Information from the Commission on the Report "A European Food and Public Health Authority: The future of scientific advice on the EU".
5- Discussion and possible opinion on the Draft Report on "Quality and safety of blood". (Doc. SANCO/SCMPMD/2000/0005)
6- Discussion and possible opinion on the Draft Report on "Update of the Opinion given by the Scientific Committee on Medicinal Products and Medical Devices on the Risk Quantification for CJD Transmission Via Substances of Human Origin".(Doc. SANCO/SCMPMD/2000/0006)
7- Information and discussion on the work of the Coordination Group "Harmonisation Risk Assessment".
8- Progress report on the work of the Working Group on "Xenotransplantation"
9- Progress report on the work of the Working Group on "Latex".
10- Information from the Commission on "Draft Directive amending Council Directive 93/42/EEC concerning medical devices incorporating stable derivatives of human blood or human blood".(Doc. SANCO/SCMPMD/2000/0003)
11- Other business:
Request from Dr.Boeynaems concerning the Opinion of the Committee on "Orphan Drugs" (Doc. SANCO/SCMPMD/2000/0004)
2. Approval of the Draft Summary Report of the plenary meeting of 16 December 1999.
The Draft Summary Report was approved as figures in document SANCO/SCMPMD/2000/0001 Final.
3. Declarations of Interest (Annual written declaration).
Forms for the Declarations of Interest for the year 2000 were distributed among the members of the Committee.
4. Information from the Commission on the Report "A European Food and Public Health Authority: The future of scientific advice on the EU".
A full discussion took place following the explanation of the document by a representative of DG SANCO.
The Chairman thanked the Commission for the information presented.
5. Discussion and possible opinion on the draft report on "Quality and Safety of Blood".
The rapporteur, Prof. Löwer, explained the document in detail, including the content of the annexes.
The Committee thanked the rapporteur and the members of the Working Group for the draft report and discussed the document, with particular emphasis on haemovigilance.
Several members proposed certain modifications on different items and Prof. Löwer redrafted several points of the report in order to take the observations made by the Committee into account.
The Committee adopted the report and opinion as in document SANCO/SCMPMD/2000/0005 Final, which contains the modifications agreed by the Committee.
6. Discussion and possible opinion on the Draft Report on "Update of the Opinion given by the Scientific Committee on Medicinal Products and Medical Devices on the Risk Quantification for CJD Transmission Via Substances of Human Origin".
Prof. Löwer, as rapporteur, explained the document and said that the Opinion given by the Committee on the Risk Quantification for CJD Transmission Via Substances of Human Origin in 1998, had been revised mainly in two points, these concerning "leukodepletion" and "Exclusion of donors at risk for TSE infection by ruminant derived material".
Many members proposed modifications to the document and opinion, and after incorporated these modifications in the draft the Committee adopted the report and opinion as figures in document SANCO/SCMPMD/2000/0006 Final
7. Information and discussion on the work of the Coordination Group "Harmonisation Risk Assessment".
Dr. Rodriguez-Farré explained that they were not many developments on the subject.
He also said that the Working Group will have a final meeting on 18 February in order to draft a document that serve as a contribution from the Scientific Committee on Medicinal Products and Medical Devices to the Working Group of the Scientific Steering Committee dealing with the subject.
He also explained the progress made by the above mentioned WG of the Scientific Steering Committee on the matter.
He also added that a comprehensive report from the WHO on the same subject is available on the Internet.
Chairman requested the rapporteur that a final document on the matter be presented at the next plenary meeting.
8. Progress report on the work of the Working Group on "Xenotransplantation".
The Chairman of the Committee said that the Working Group created to deal with this subject has produced a preliminary report as an information document.
This document is only addressed to the Group and to draw the attention from the Commission on the subject.
Dr. Jones proposed Dr. De Jong as Chairman of the group taking into account that he was unable to continue to chair the group. And also proposed Dr. Vannier as a member of the group because of his the veterinary experience.
The Committee agreed.
9. Progress report on the work of the Working Group on "Latex".
Dr. de Jong said that the Working Group has difficulties to give a response to certain requests, and that will be necessary to have three more meeting before they could draft a report and opinion.
He said that the scientific publications are too divergent, and therefore it is indispensable to reflect carefully before proposing an opinion.
10. Information from the Commission on "Draft Directive amending Council Directive 93/42/EEC concerning medical devices incorporating stable derivatives of human blood or human blood".
M. Lacerda, representative from DG Enterprise, said that the Council adopted a Common Position which, with a Council and Commission's Opinion, will be sent to the European Parliament for the second reading.
Once the legislative process is concluded ,it is expected that the new Directive will cover Medical Devices that incorporates, as integral part, a human blood derivative.
The European Agency for the Evaluation of Medicinal Products (EMEA) will evaluate the quality and safety of the derivative of blood and its scientific opinion must be included in the documentation concerning the device.
The Notified Body may not deliver the certificate (CE Marking of Conformity) if the EMEA's scientific opinion is unfavourable.
The representative of the EMEA explained the common procedure applied by the Agency and the implication on medical devices.
11. Other business.
Request from Dr.Boeynaems concerning the Opinion of the Committee on "Orphan Drugs":
Prof. Boeynaems said that a proposal for a regulation on "Orphan Drugs" has been made by the Commission and that the Opinions given by the Committee on "Clinical Superiority" and "Similarity" are more complete that those which figure in the proposal.
Certain members said that the proposal did not fully take into account the opinions given by the Committee.
Not other points.
