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.