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Directorate-General for Health and Food Safety
List of participants
MEMBERS
Prof. J.M. Boeynaems, Prof. J.R. Claude, Dr. W.H. De Jong, Prof. J.G. Descotes, Prof. M. Giovannini, Prof. J.A. Guimarães Morais, Dr. K.H. Jones, Dr. J. Löwer, Prof. Dr. H.W.J. Marquardt, Dr. E. Rodriguez Farré, Prof. M. Silbermann
APOLOGIES
Dr. R. Dobbelaer, Prof. P. Preziosi, Prof. F. Sjöqvist, Prof. K. Turnheim, Prof. D.F. Williams
COMMISSION
Mme. K.Howe (DG III), M. G. Fracchia (DG XXIV), Mr. A. Lacerda (DG III), Mme. M. De Solà (DG XXIV), Mme. M. Theofilatou (DG XII), Dr. A. Sanabria (DG XXIV)
EMEA
Dr. J. Purves
EXPERTS
Mr. K.F. Bopp
Dr. Jones, Chairman of the SCMPMD, opened the meeting saying that Prof. Preziosi is convalescing from heart surgery, and wished him, on behalf of all members, a speedy recuperation.
He welcomed Dr. Giovannini as a new member of the Committee, and noted that he could help the Committee on subjects such as paediatric pharmaceutical products.
1. Approval of the Agenda
The agenda was adopted as follows:
1- Approval of the agenda. (XXIV/SCMPMD/99.103)
2- Approval of the Draft Summary Report of the plenary meeting of 14 April 1999. (XXIV/SCMPMD/99.101 Rev. 1).
3- Information and discussion on the work of the Coordination Group "Harmonisation Risk Assessment".
4. Information of the Commission Services about the new Commission.
5- 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).
6- Xenotransplantation:
a) Information on the activities of the Council of Europe in the area of Xenotransplantation. (Mr. Karl Friedrich Bopp.-Health Division, Council of Europe.
b) Discussion.
7- Discussion on the SCMPMD Working Group on "Quality and safety of blood".
8- Dioxine: Information and discussion on the possible influence of this product in medicinal products and medical devices.
9- New information on possible risk of transmitting CJD via blood.
10- Implications of the problem of the Year 2000 (Y2K) for Medical Devices: Information from DG III.
11- Guidelines of EMEA:
Information from EMEA observer on Process for development of Pharmaceutical Guidelines.
Veterinary Guidelines.
12- Other business.
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/99.101 Final.
3. Information and discussion on the work of the Coordination Group "Harmonisation Risk Assessment".
Dr. Rodriguez-Farré, as rapporteur of the Working Group of the SCMPMD and representative in the W.G. of the Scientific Steering Committee, said that the only document that exists is that discussed in the last plenary meeting.
The Working Group of the SSC will meet in the afternoon, in order to examine the contributions of different Scientific Committees.
He informed the Committee that the representatives of the other Scientific Committees would take into account economical aspects in the risk analysis.
He distributed a document from Dr. Bridges, chairman of W.G. of the SSC, that would be the base for the discussion in the meeting of the W.G. of the SSC, to held in the afternoon.
The Chairman said that this matter was extremely important for the Scientific Committee on Medicinal Products and Medical Devices, taking into account the specific weight that this subject has in the evaluation of the medicinal products, and requested the representative of the EMEA if the Agency has already a document on this.
The representative of the EMEA said that the Agency has a lot of information from the industry that could be useful in order to study the subject, but stated that risk analysis is very complex, because several parameters must be taken into account.
The rapporteur reminded the members that the report will take also in consideration risk analysis for medical devices.
He said that the WG of the SCMPMD will meet in October in order to prepare a document that takes into account the wish expressed by the members of the SCMPMD and the discussion of the WG of the SSC, and also the discussion of the experts present in the meeting of the WG.
The Committee agreed that the point will figure on the Agenda of the Plenary Meeting of the Committee in October, and that a document of the WG be discussed.
The Chairman said that it is important not to waste this opportunity that is given to the Committee to draft a report on a subject which is very interesting for the evaluation of medicinal products and medical devices.
4. Information of the Commission Services about the new Commission.
Mme. De Solà, representative of DG XXIV, explained that today the European Parliament could give the OK to the new Commission.
She told the members about the competences of the new General Directorate that will replace DG XXIV.
The article 152 of the Treaty of Amsterdam gives certain new competences on Public Health to the Commission, and our Committee will be more or less implicated in this job. A Task Force will be created for the application of this article.
Concerning the new structure of DG XXIV, Mme. De Solà said that if the European Parliament give their OK to the new Commission, then it will adopt on Saturday a new organigram, and as announced DG XXIV will be the Directorate General for "Consumers and Public Health". In the future the roman numerals of DG's will disappear, and each DG will have an acronym in order to remember their names better.
This Directorate General for "Consumers and Public Health" will be formed from the old structure of DG XXIV plus the Directorate dealing with "veterinary " and "phytosanitary" aspects from the old DG VI, plus the unit of the former DG V charged with "public health" subjects.
This could be just the first restructuration because another is intended in February 2000, and could include the Directorate of Scientific Committees, in order to separate the legislative aspects from the scientific opinions and control of food.
It is known that a group of "sages" is making a report on the future of the scientific committees. This study should be finalised in the next months.
On the other hand, the President of the Commission had already said to the Parliament that one possibility of treating the current problems of food safety would be the creation of an Agency for these issues.
In any case the Commission has the obligation to cover for the health of consumers in all aspects, and mainly, the safety of foods. The scientific committees will have an important role in this area.
The Chairman thanked Mme. De Solà for the information, and stated that the SCMPMD will continue to give their opinion on the subjects requested by the Commission. He felt that the role of the Committee will be reinforced by the new structure.
5. 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).
In absence of the rapporteur, Dr. De Jong said that only two subjects are lacking in order to finalise the final report. These subjects concern the finalisation of a document from CEN and another of DG III.
The Chairman said that a final report of the W.G. should be available before the next plenary meeting of the Committee.
6. Xenotransplantation:
a) Information on the activities of the Council of Europe in the area of Xenotransplantation. (Mr. Karl Friedrich Bopp.-Health Division, Council of Europe.
b) Discussion.
The representative of the Council of Europe thanked the Committee for the invitation to explain the work that the Council is making on the subject.
He informed that the Council of Europe was founded in 1949, that at the moment it has 41 Member States and that their headquarters are in Strasbourg.
He said that the principles of the Council of Europe applicable in the case are:
- non-commercialisation of substances of human origin;
- ensure the dignity of the human being;
- maintenance and further realisation of human rights and fundamental freedoms;
- protection of donors and recipients.
Into this area the objectives achieved by the the following activities are:
- study the ethical, legal and organisational aspects of organ transplantation, with the view to ensuring quality and increasing availability of organs;
- analyse the possible ethical and organisational impact of new scientific developments.
The organisms involved in the subject are:
- Committee of Ministers
- European Health Committee (CDSP)
- Steering Committee on Bioethics (CDBI)
- Working Party on Xenotransplantation.
The legal tools are:
- Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine. N° 164 on Human Rights and Biomedicine (1997).
- Protocol to the Convention on human rights and biomedicine on the prohibition of cloning human beings.
- Protocol to the Convention on human rights and biomedicine on organ transplantation (in consult period).
- Recommendation N° (97) 15 on Xenotransplantation.
- State of the Art report on Xenotransplantation.
He explained each legal body and informed the Committee that the Working Groups meet two time by year.
The Chairman thanked the representative of the Council of Europe for his information on the subject.
He said that the Committee must find the more interesting scientific points on the subject and requested to form a group to identify these points.
The Committee agreed that Prof. Williams, Dr. de Jong, Dr. Silberman, Prof. Löwer and Prof. Descotes form part of this group. Dr. Jones will chair the group.
Nevertheless certain members of the Committee also wished that external experts on the subject be integrated in the Working Group, taking into account that the nominated members are not specialists in the matter.
The Chairman requested the chairman of the group that after the first meeting he identifies the external experts needed in order to invite them to the future meetings of the Working Group.
He requested also the representative of the EMEA their contribution to the work.
The EMEA representative responded that a document of the EMEA on the subject will be sent to the Working Group.
7. Discussion on the SCMPMD Working Group on "Quality and safety of blood".
The rapporteur informed that the Working Group, created at the last Plenary Meeting of the SCMPMD, in order to draft a report on this subject, will meet on 17th. September
He also informed the Committee on the external experts chosen in order to help the members of the SCMPMD integrated in the group in the drafting of the document.
In response to a question made by a member, concerning the mandate of the Committee on this subject, the rapporteur said that the job of the group will be to respond to the requests made by the Commission.
The representative of Council of Europe said that on this matter the Council has a Working Group that meets regularly in order to review the improvements on the subject.
He gave the secretariat a book on this issue edited by the Council of Europe, and informed the Committee on the composition of their Working Group.
The Chairman thanked Dr. Bopp and the rapporteur for the information given.
8. Dioxine: Information and discussion on the possible influence of this product in medicinal products and medical devices.
The Committee took notice of the FDA paper, giving recommendations to the USA industry concerning the procedures to follow in order to avoid the risk of a contamination of pharmaceutical products with dioxine that could contain raw materials from Europe (mainly Belgium, France and The Netherlands), and acknowledged that this is certainly based on the application of the Precautionary Principles, and probably on some scientific evidence which nevertheless was not provided nor was it discussed at the meeting.
At the request of the chairman the representative of the EMEA said that the Agency also had a paper on the subject, which can be found on their Internet site.
9. New information on possible risk of transmitting CJD via blood.
Dr. Löwer informed the Committee on the latest news on the subject and commented on the messures taken by the FDA in order to prohibit the donations of blood from people who were living in the United Kingdom pending a certain period of time.
He informed the members also on the researches made with animals in order to study the possible transmission of CJD via blood, and cited two models of infected animals.
Taking into account that we agreed to review the document "The risk quantification for CJD transmission via substances of human origin" adopted in October 1998, in the light of improvements in the subject the new papers deserves to be evaluated carefully.
The chairman proposed that this item figures in the Agenda of a future meeting, and that the Working Group on the subject would meet again in order to give an opinion whether it is necessary to modify the above-mentioned document or not.
The Commission said that if the Committee considers new research necessary to clarify the subject, this could be requested from DG XII, for inclusion in their research programme.
Finally the Chairman reminded the members that the evaluation of the Committee should be based only on a strict scientific basis.
10. Implications of the problem of the Year 2000 (Y2K) for Medical Devices: Information from DG III.
The representative of DG III explained the subject.
She said that it is well known that computer systems may experience severe problems on December 31st 1999 at midnight. These problems could also affect some electrically powered medical devices with built-in computer circuits, including much critical care equipment.
It is important that medical devices are Year 2000 compliant. This means that neither performance nor functionality is affected by dates prior to, during and after the year 2000. Devices that are not date-aware are automatically year 2000 compliant.
The year 2000 problem has received ample footage in the popular press, however, according to experts, for medical devices much of what is written is unsubstantiated by reality. When these problems are investigated on a case by case basis by the technical experts of the health ministries then no risks to patients or users can be identified.
She stated that the problems in the medical devices industry are less that in other industries because:
- medical device manufacturers are obliged to maintain comprehensive records and be able to trace critical components back to their source;
-.products are designed to comply with international safety standards and the manufacturers of devices meeting the European Directives have to complete a risk assessment;
- manufacturers are obliged to maintain comprehensive records and be able to trace critical components back to their source.
Finally, she said that Health Ministries in Member States are working with their healthcare providers and manufacturers to establish and solve any problems that do exist, identifying the problem, notifying it and moving out or updating if necessary.
The Chairman thanked the representative of DG III for her explanation on the subject, and askeded the members if they had any scientific questions on the matter.
Taking into account that no questions were made, the Chairman finalised the discussion on this item.
11. Guidelines of EMEA:
Information from EMEA observer on Process for development of Pharmaceutical Guidelines.
Veterinary Guidelines.
The representative of EMEA informed on the Process for development of Pharmaceutical Guidelines.
He said that the initiation of a Guideline is based on the experience, the science, and meant to be practical.
The source of concepts are the scientific literature, the CPMP Scientific Advice and the CPMP dossier evaluation in the case of medicinal products for humans.
In the first stage the concepts are written by a Working Party that develops a Draft Concept Paper. The Concept Paper is then discussed in the CPMP, which can adopte it for release or reject it.
If the Concept Paper is adopted then a Working Group drafts a Guideline, taking into account the comments received on the Concept Paper, and finally the Draft Guideline is proposed to CPMP for release and consultation.
Afterwards the Draft Guideline is put in consultation for a period from 3 to 6 months, after which the Working Party revises the draft in order to discuss the observations made, and a meeting with interested parties is scheduled if needed.
The Pre-Final Draft is discussed in the CPMP, and if adopted the Guideline enters into force in 6 months.
Several CPMP Guidelines had been adopted on subjects such as "Efficacy Topics", "Multidisciplinary Topics", Biotechnology Quality Topics", "Safety Topics" and "Pharmacovigilance Topics".
This explanation was related to the Guidelines on Medicinal Products for Human use. No mention was made concerning the Guidelines on Medicinal Products intended for Veterinary use.
The Chairman requested the representative of the EMEA to inform the SCMPMD on the future Guidelines that the Agency intends to discuss and the planning with dates for the procedure.
He said that the SCMPMD could choose certain Draft Guidelines, interesting from the point of view of human protection, to study them from a scientific point of view. A member of the Committee could be mandated for this job and report to the SCMPMD.
The representative of EMEA said that for next meeting he could inform the Committee on the request made on the subject, and expressed their wish to collaborate with SCMPMD.
The Chairman thanked the representative of the EMEA for his intervention.
12. Other business.
The Chairman congratulated the new Commission for their nomination.
No other points.
MEMBERS
Prof. J.M. Boeynaems, Prof. J.R. Claude, Dr. W.H. De Jong, Prof. J.G. Descotes, Prof. M. Giovannini, Prof. J.A. Guimarães Morais, Dr. K.H. Jones, Dr. J. Löwer, Prof. Dr. H.W.J. Marquardt, Dr. E. Rodriguez Farré, Prof. M. Silbermann
APOLOGIES
Dr. R. Dobbelaer, Prof. P. Preziosi, Prof. F. Sjöqvist, Prof. K. Turnheim, Prof. D.F. Williams
COMMISSION
Mme. K.Howe (DG III), M. G. Fracchia (DG XXIV), Mr. A. Lacerda (DG III), Mme. M. De Solà (DG XXIV), Mme. M. Theofilatou (DG XII), Dr. A. Sanabria (DG XXIV)
EMEA
Dr. J. Purves
EXPERTS
Mr. K.F. Bopp
Dr. Jones, Chairman of the SCMPMD, opened the meeting saying that Prof. Preziosi is convalescing from heart surgery, and wished him, on behalf of all members, a speedy recuperation.
He welcomed Dr. Giovannini as a new member of the Committee, and noted that he could help the Committee on subjects such as paediatric pharmaceutical products.
1. Approval of the Agenda
The agenda was adopted as follows:
1- Approval of the agenda. (XXIV/SCMPMD/99.103)
2- Approval of the Draft Summary Report of the plenary meeting of 14 April 1999. (XXIV/SCMPMD/99.101 Rev. 1).
3- Information and discussion on the work of the Coordination Group "Harmonisation Risk Assessment".
4. Information of the Commission Services about the new Commission.
5- 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).
6- Xenotransplantation:
a) Information on the activities of the Council of Europe in the area of Xenotransplantation. (Mr. Karl Friedrich Bopp.-Health Division, Council of Europe.
b) Discussion.
7- Discussion on the SCMPMD Working Group on "Quality and safety of blood".
8- Dioxine: Information and discussion on the possible influence of this product in medicinal products and medical devices.
9- New information on possible risk of transmitting CJD via blood.
10- Implications of the problem of the Year 2000 (Y2K) for Medical Devices: Information from DG III.
11- Guidelines of EMEA:
Information from EMEA observer on Process for development of Pharmaceutical Guidelines.
Veterinary Guidelines.
12- Other business.
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/99.101 Final.
3. Information and discussion on the work of the Coordination Group "Harmonisation Risk Assessment".
Dr. Rodriguez-Farré, as rapporteur of the Working Group of the SCMPMD and representative in the W.G. of the Scientific Steering Committee, said that the only document that exists is that discussed in the last plenary meeting.
The Working Group of the SSC will meet in the afternoon, in order to examine the contributions of different Scientific Committees.
He informed the Committee that the representatives of the other Scientific Committees would take into account economical aspects in the risk analysis.
He distributed a document from Dr. Bridges, chairman of W.G. of the SSC, that would be the base for the discussion in the meeting of the W.G. of the SSC, to held in the afternoon.
The Chairman said that this matter was extremely important for the Scientific Committee on Medicinal Products and Medical Devices, taking into account the specific weight that this subject has in the evaluation of the medicinal products, and requested the representative of the EMEA if the Agency has already a document on this.
The representative of the EMEA said that the Agency has a lot of information from the industry that could be useful in order to study the subject, but stated that risk analysis is very complex, because several parameters must be taken into account.
The rapporteur reminded the members that the report will take also in consideration risk analysis for medical devices.
He said that the WG of the SCMPMD will meet in October in order to prepare a document that takes into account the wish expressed by the members of the SCMPMD and the discussion of the WG of the SSC, and also the discussion of the experts present in the meeting of the WG.
The Committee agreed that the point will figure on the Agenda of the Plenary Meeting of the Committee in October, and that a document of the WG be discussed.
The Chairman said that it is important not to waste this opportunity that is given to the Committee to draft a report on a subject which is very interesting for the evaluation of medicinal products and medical devices.
4. Information of the Commission Services about the new Commission.
Mme. De Solà, representative of DG XXIV, explained that today the European Parliament could give the OK to the new Commission.
She told the members about the competences of the new General Directorate that will replace DG XXIV.
The article 152 of the Treaty of Amsterdam gives certain new competences on Public Health to the Commission, and our Committee will be more or less implicated in this job. A Task Force will be created for the application of this article.
Concerning the new structure of DG XXIV, Mme. De Solà said that if the European Parliament give their OK to the new Commission, then it will adopt on Saturday a new organigram, and as announced DG XXIV will be the Directorate General for "Consumers and Public Health". In the future the roman numerals of DG's will disappear, and each DG will have an acronym in order to remember their names better.
This Directorate General for "Consumers and Public Health" will be formed from the old structure of DG XXIV plus the Directorate dealing with "veterinary " and "phytosanitary" aspects from the old DG VI, plus the unit of the former DG V charged with "public health" subjects.
This could be just the first restructuration because another is intended in February 2000, and could include the Directorate of Scientific Committees, in order to separate the legislative aspects from the scientific opinions and control of food.
It is known that a group of "sages" is making a report on the future of the scientific committees. This study should be finalised in the next months.
On the other hand, the President of the Commission had already said to the Parliament that one possibility of treating the current problems of food safety would be the creation of an Agency for these issues.
In any case the Commission has the obligation to cover for the health of consumers in all aspects, and mainly, the safety of foods. The scientific committees will have an important role in this area.
The Chairman thanked Mme. De Solà for the information, and stated that the SCMPMD will continue to give their opinion on the subjects requested by the Commission. He felt that the role of the Committee will be reinforced by the new structure.
5. 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).
In absence of the rapporteur, Dr. De Jong said that only two subjects are lacking in order to finalise the final report. These subjects concern the finalisation of a document from CEN and another of DG III.
The Chairman said that a final report of the W.G. should be available before the next plenary meeting of the Committee.
6. Xenotransplantation:
a) Information on the activities of the Council of Europe in the area of Xenotransplantation. (Mr. Karl Friedrich Bopp.-Health Division, Council of Europe.
b) Discussion.
The representative of the Council of Europe thanked the Committee for the invitation to explain the work that the Council is making on the subject.
He informed that the Council of Europe was founded in 1949, that at the moment it has 41 Member States and that their headquarters are in Strasbourg.
He said that the principles of the Council of Europe applicable in the case are:
- non-commercialisation of substances of human origin;
- ensure the dignity of the human being;
- maintenance and further realisation of human rights and fundamental freedoms;
- protection of donors and recipients.
Into this area the objectives achieved by the the following activities are:
- study the ethical, legal and organisational aspects of organ transplantation, with the view to ensuring quality and increasing availability of organs;
- analyse the possible ethical and organisational impact of new scientific developments.
The organisms involved in the subject are:
- Committee of Ministers
- European Health Committee (CDSP)
- Steering Committee on Bioethics (CDBI)
- Working Party on Xenotransplantation.
The legal tools are:
- Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine. N° 164 on Human Rights and Biomedicine (1997).
- Protocol to the Convention on human rights and biomedicine on the prohibition of cloning human beings.
- Protocol to the Convention on human rights and biomedicine on organ transplantation (in consult period).
- Recommendation N° (97) 15 on Xenotransplantation.
- State of the Art report on Xenotransplantation.
He explained each legal body and informed the Committee that the Working Groups meet two time by year.
The Chairman thanked the representative of the Council of Europe for his information on the subject.
He said that the Committee must find the more interesting scientific points on the subject and requested to form a group to identify these points.
The Committee agreed that Prof. Williams, Dr. de Jong, Dr. Silberman, Prof. Löwer and Prof. Descotes form part of this group. Dr. Jones will chair the group.
Nevertheless certain members of the Committee also wished that external experts on the subject be integrated in the Working Group, taking into account that the nominated members are not specialists in the matter.
The Chairman requested the chairman of the group that after the first meeting he identifies the external experts needed in order to invite them to the future meetings of the Working Group.
He requested also the representative of the EMEA their contribution to the work.
The EMEA representative responded that a document of the EMEA on the subject will be sent to the Working Group.
7. Discussion on the SCMPMD Working Group on "Quality and safety of blood".
The rapporteur informed that the Working Group, created at the last Plenary Meeting of the SCMPMD, in order to draft a report on this subject, will meet on 17th. September
He also informed the Committee on the external experts chosen in order to help the members of the SCMPMD integrated in the group in the drafting of the document.
In response to a question made by a member, concerning the mandate of the Committee on this subject, the rapporteur said that the job of the group will be to respond to the requests made by the Commission.
The representative of Council of Europe said that on this matter the Council has a Working Group that meets regularly in order to review the improvements on the subject.
He gave the secretariat a book on this issue edited by the Council of Europe, and informed the Committee on the composition of their Working Group.
The Chairman thanked Dr. Bopp and the rapporteur for the information given.
8. Dioxine: Information and discussion on the possible influence of this product in medicinal products and medical devices.
The Committee took notice of the FDA paper, giving recommendations to the USA industry concerning the procedures to follow in order to avoid the risk of a contamination of pharmaceutical products with dioxine that could contain raw materials from Europe (mainly Belgium, France and The Netherlands), and acknowledged that this is certainly based on the application of the Precautionary Principles, and probably on some scientific evidence which nevertheless was not provided nor was it discussed at the meeting.
At the request of the chairman the representative of the EMEA said that the Agency also had a paper on the subject, which can be found on their Internet site.
9. New information on possible risk of transmitting CJD via blood.
Dr. Löwer informed the Committee on the latest news on the subject and commented on the messures taken by the FDA in order to prohibit the donations of blood from people who were living in the United Kingdom pending a certain period of time.
He informed the members also on the researches made with animals in order to study the possible transmission of CJD via blood, and cited two models of infected animals.
Taking into account that we agreed to review the document "The risk quantification for CJD transmission via substances of human origin" adopted in October 1998, in the light of improvements in the subject the new papers deserves to be evaluated carefully.
The chairman proposed that this item figures in the Agenda of a future meeting, and that the Working Group on the subject would meet again in order to give an opinion whether it is necessary to modify the above-mentioned document or not.
The Commission said that if the Committee considers new research necessary to clarify the subject, this could be requested from DG XII, for inclusion in their research programme.
Finally the Chairman reminded the members that the evaluation of the Committee should be based only on a strict scientific basis.
10. Implications of the problem of the Year 2000 (Y2K) for Medical Devices: Information from DG III.
The representative of DG III explained the subject.
She said that it is well known that computer systems may experience severe problems on December 31st 1999 at midnight. These problems could also affect some electrically powered medical devices with built-in computer circuits, including much critical care equipment.
It is important that medical devices are Year 2000 compliant. This means that neither performance nor functionality is affected by dates prior to, during and after the year 2000. Devices that are not date-aware are automatically year 2000 compliant.
The year 2000 problem has received ample footage in the popular press, however, according to experts, for medical devices much of what is written is unsubstantiated by reality. When these problems are investigated on a case by case basis by the technical experts of the health ministries then no risks to patients or users can be identified.
She stated that the problems in the medical devices industry are less that in other industries because:
- medical device manufacturers are obliged to maintain comprehensive records and be able to trace critical components back to their source;
-.products are designed to comply with international safety standards and the manufacturers of devices meeting the European Directives have to complete a risk assessment;
- manufacturers are obliged to maintain comprehensive records and be able to trace critical components back to their source.
Finally, she said that Health Ministries in Member States are working with their healthcare providers and manufacturers to establish and solve any problems that do exist, identifying the problem, notifying it and moving out or updating if necessary.
The Chairman thanked the representative of DG III for her explanation on the subject, and askeded the members if they had any scientific questions on the matter.
Taking into account that no questions were made, the Chairman finalised the discussion on this item.
11. Guidelines of EMEA:
Information from EMEA observer on Process for development of Pharmaceutical Guidelines.
Veterinary Guidelines.
The representative of EMEA informed on the Process for development of Pharmaceutical Guidelines.
He said that the initiation of a Guideline is based on the experience, the science, and meant to be practical.
The source of concepts are the scientific literature, the CPMP Scientific Advice and the CPMP dossier evaluation in the case of medicinal products for humans.
In the first stage the concepts are written by a Working Party that develops a Draft Concept Paper. The Concept Paper is then discussed in the CPMP, which can adopte it for release or reject it.
If the Concept Paper is adopted then a Working Group drafts a Guideline, taking into account the comments received on the Concept Paper, and finally the Draft Guideline is proposed to CPMP for release and consultation.
Afterwards the Draft Guideline is put in consultation for a period from 3 to 6 months, after which the Working Party revises the draft in order to discuss the observations made, and a meeting with interested parties is scheduled if needed.
The Pre-Final Draft is discussed in the CPMP, and if adopted the Guideline enters into force in 6 months.
Several CPMP Guidelines had been adopted on subjects such as "Efficacy Topics", "Multidisciplinary Topics", Biotechnology Quality Topics", "Safety Topics" and "Pharmacovigilance Topics".
This explanation was related to the Guidelines on Medicinal Products for Human use. No mention was made concerning the Guidelines on Medicinal Products intended for Veterinary use.
The Chairman requested the representative of the EMEA to inform the SCMPMD on the future Guidelines that the Agency intends to discuss and the planning with dates for the procedure.
He said that the SCMPMD could choose certain Draft Guidelines, interesting from the point of view of human protection, to study them from a scientific point of view. A member of the Committee could be mandated for this job and report to the SCMPMD.
The representative of EMEA said that for next meeting he could inform the Committee on the request made on the subject, and expressed their wish to collaborate with SCMPMD.
The Chairman thanked the representative of the EMEA for his intervention.
12. Other business.
The Chairman congratulated the new Commission for their nomination.
No other points.
