Directorate General Health & Consumers
List of participants
Prof. J.M. Boeynaems, Prof. J.R. Claude, Dr. W.H. De Jong, Dr. R. Dobbelaer, Prof. M. Giovannini, Prof. J.A. Guimarães Morais, Dr. K.H. Jones, Dr. J. Löwer, Prof. M. Silbermann, Prof. D.F. Williams
Prof. J.G. Descotes, Prof. Dr. H.W.J. Marquardt, Prof. P. Preziosi, Dr. E. Rodriguez Farré, Prof. F. Sjöqvis, Prof. K. Turnheim
Mme. K.Howe (DG ENTR), M. G. Fracchia (DG SANCO), Mme. M. De Solà (DG SANCO), Dr. H. Martin (DG SANCO), Mme. Delaney (DG SANCO), Dr. A. Sanabria (DG XXIV)
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 15 September 1999. (XXIV/SCMPMD/99.137)
3- Discussion and possible opinion on a Draft Report on the «Draft Guidelines on the use of specified risk materials for the manufacture of implantable medical devices».(XXIV/SCMPMD/99.100 Rev.1).
4- Progress report on the work of the Working Group on "Quality and safety of blood".
5- Progress report on the work of the Working Group on "Impact of CJD".
6- Information and discussion on the work of the Co-ordination Group "Harmonisation Risk Assessment". (XXIV/SCMPMD/99.099 Rev.1)
7- Information on the work of the Working Group on "Xenotransplantation"
8- Progress report on the work of the Working Group on "Latex".
9- Information on "The relevance of leachable phthalates in medicinal products and medical devices".
10- Other business.
-Dates Plenary Meetings for 2000.
2. Approval of the Draft Summary Report of the plenary meeting of 10 February 1998.
The Draft Summary Report was approved as figures in document XXIV/SCMPMD/99.137 Final.
3. Discussion and possible opinion on a Draft Report on the «Draft Guidelines on the use of specified risk materials for the manufacture of implantable medical devices».(XXIV/SCMPMD/99.100 Rev.1).
The report was introduced by the rapporteur, Dr. Williams. After discussion the report and the opinion were adopted with minor modifications as figure in the document XXIV/SCMPMD/99.100 Final.
4. Progress report on the work of the Working Group on "Quality and safety of blood".
Prof. Löwer, as rapporteur, explained the issue, and informed the Committee that the draft report was not yet finished because several interesting contributions of members of the WG were missing.
He stated that this is a subject which has been treated by several international organisations, such as WHO, for years. Nevertheless a first draft report will be available in the next plenary meeting of the Committee.
He informed the Committee also about the exclusions of donors in USA and in Canada, and the criteria used to exclude certain donors.
Finally he emphasised the need to have a good system of hemovigilance and the lack of epidemiological data.
This point will figure on the agenda of the next plenary meeting.
5. Progress report on the work of the Working Group on "Impact of CJD".
The rapporteur, Prof. Löwer, informed the Committee that the working group on "Impact of CJD" is revising the opinion and report on "The risk quantification for CJD transmission via substances of human origin", adopted by the SCMPMD on 21 October 1998, in order to take new scientific data on the subject into account.
Two interesting documents on blood fractionation were published recently and are going to be evaluated.
Also certain American studies concerning the exclusion of donors which had lived during a certain period in UK, should be evaluated by the WG.
In January 2000 the WG will meet again in order to prepare a draft report on the necessity to update the report mentioned in the first paragraph.
The draft report will be submitted to the Plenary of the Committee that will be held in February 2000.
6. Information and discussion on the work of the Co-ordination Group "Harmonisation Risk Assessment".
In the absence of Dr. Rodriguez-Farré, Dr. Silberman informed the Committee on the progress of the WG, and on the work of the WG of the Scientific Steering Committee on the same subject.
Several members expressed their wish that a chapter on "Paediatric Medicinal Products" and another concerning "Alternative Medicines" figure in the document. Nevertheless other members considered that the inclusion of a chapter on " Alternatives Medicines" could give rise to philosophical discussions and were against the introduction of this chapter. These same members could accept to introduce several paragraphs on this subject but from a general point of view.
7. Information on the work of the Working Group on "Xenotransplantation"
The Chairman explained the progress made by the group in the first meeting, and underlined that taking into account the lack of organs for transplantation this is a subject that is debated in several fora.
He explained that the group discussed the issue and a position paper was agreed by the members of the WG. This paper will be the starting point for a more detailed document that will be discussed by experts on the subject during a seminar that must be organised soon. The WG will meet once more.
The work will be difficult and to have a final draft twelve or more months will be necessary.
He thanked the Secretariat for the papers on the subject distributed among the members.
8. Progress report on the work of the Working Group on "Latex".
Dr. de Jong said that after two meetings of the WG he felt a Draft report will be available follows the meeting of February 2000. Since 17 questions were posed, and this is a considerable work.
Certain members said that the high number of questions complicated the work of the Committee and would prefer to have a more general question.
9. Information on "The relevance of leachable phthalates in medicinal products and medical devices".
The Commission informed the Committee that in 2 years the Scientific Committee on Toxicity, Ecotoxicity and the Environment had adopted several opinions on the "Phthalates" in toys and mordedore for babys.
The representative of DG Enterprise said that several questions on this subject were addressed at this DG concerning the safety of certain medical devices that could contain Phatalates (blood containers, catheters for medical use, dental prosthesis).
Several members opined that this is not a new problem, and that is in discussion in several groups among the world. Nevertheless they admitted the importance of the subject and were ready to initiate a risk evaluation if the Commission requested it.
Several members said that in the case of the blood containers it will be necessary to evaluate also if alternatives are safer that the current product, and take into account that the products now in use to fabricate these containers help to conserve erythrocytes.
The Committee did not feel that on this point there was a need for urgent action apart from monitoring the situation. Should new information become available in the future the Committee will inform the Commission.
10. Other business.
-Dates Plenary Meetings for 2000:
The following dates were adopted:
16 February 2000
12 April 2000
27 June 2000
4 October 2000
8 November 2000
13 December 2000
The secretariat distributed a letter from Danisco concerning the subject.
-Information from the Chairman:
The Chairman informed on the last Plenary Meeting of the Scientific Steering Committee, and mainly on the report "The future of scientific advice in the EU".
-Information from the Commission:
The representative of DG Sanco informed that the procedure to select the members of the Scientific Committees for a next period of time would be launched in the next months.
Not other points.