|
A EUROPEAN TECHNOLOGY PLATFORM |
Working
Group 3 “Horizontal Issues” - Report
Brussels,
2 December 2005
Final, 19 December 2005
|
HMA
UK / S. Dean (Chair) IFAH
/ P. Jones (Vice-chair) CEVA / M. Chaton-Schaffner COPA-COGECA / P. De Winter CVO Netherlands / M. Weijtens Fort Dodge / R. Banks FVE / J. Vaarten HMA Hungary / T. Soos INRA / F. Lantier
(for A. Rodolakis) Intervet / M. Gravendijck Merial / J. Lechenet Liverpool University / J.
Scudamore (minutes) OIE / Ch. Bruschke VLA-OIE
/ S. Edwards Pfizer / A. Peters Universidade Técnica Lisboa / T. Fernandes IFAH-Europe / D. O’Brien IFAH-Europe / H. Marion |
Observers European
Commission / B. Arbelot European Commission / A. Gautrais European Commission / I. Minguez-Tudela European
Commission / P. Vialatte European
Commission / P. Steinmetz Apologies European Pharmacopoeia / P. Castle ILRI
/ B. Perry Institute for Animal Health / D.
MacKay |
Agenda
|
Welcome Introduction to the meeting |
S. Dean |
|
Review and approval of the minutes of the last
meeting (13/10/05) |
S. Dean
/ All |
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Introduction of draft Scientific Research Agenda
(SRA) |
J.
Scudamore |
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Discussion of draft Scientific Research Agenda
(SRA) |
All |
|
|
|
Review and conclusions on SRA |
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Summary and Close of
the Meeting
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|
Minutes
Introduction
1. Mr Declan O’Brien, Chair of the
European Technology Platform for Global Animal Health (ETPGAH), updated the
group on the progress to date. The chairs of the 3 working groups and the
secretariat had met to coordinate the agenda for the meetings and to discuss
the layout and content of the Strategic Research Agenda (SRA). The Executive
Board of the Platform discussed a range of issues including the work of the 3
groups during a recent teleconference. Mr O’Brien was pleased to announce that
the vision document for the platform had been finalised. IFAH-Europe had
arranged for 4000 copies to be printed. He asked representatives to assist in
distributing the vision document as widely as possible. Good progress was being
made. Mr O’Brien thanked Professor Scudamore for his work in producing the
vision document and the initial drafts of the Strategic Research Agenda.
Approval of the notes of the meeting
on 13 October 2005
2. A number of changes were requested to
the minutes of the last meeting most of which were editorial and would be dealt
with by the secretariat. These included the paragraph numbering and some
duplication of reporting in the body of the notes.
The Strategic Research Agenda (SRA)
3.
Professor
Scudamore summarised the current position with the development of the SRA. An
initial rough draft had been prepared for use at the working group meetings. It
was anticipated that this would be the subject of considerable revision
following the meetings. The initial draft was based on the outcome of the first
series of working group meetings which had concentrated on research needs and
rationale for the research requirements. Consequently there was little in the
initial SRA detailing specific research requirements. It was important to
identified specific areas for research during the current meeting of the
working group. In addition methods to overcome the barriers to the development
and delivery of new and improved tools to control diseases of major importance
were needed.
4.
Professor
Scudamore outlined the proposed format for the SRA document and re-emphasised
the importance of including specific research requirements. It was also
important to develop an action plan for the implementation of the SRA.
Potential sources of funding would need to be identified especially as the EU
Framework 7 funding was only one of a number of potential sources.
Discussion on topics in the draft
SRA
5.
It was
agreed that the working group would discuss the SRA under the headings used in
the initial draft. These included: product needs, priorities, basic research,
technology transfer, regulatory issues, horizontal issues, global perspective
and implementation plan.
Product needs.
6.
It was
important to use consistent terminology. Veterinary medicines would be used to
cover the whole group of products and within this category there were vaccines
and pharmaceuticals. It would be important to include antimicrobials in the
report as these had important uses further down the food chain and their use
had consequences for human health. Some members felt the draft was too focussed
on vaccines but others commented that vaccines could be the key to future
prophylaxis of a number of conditions under discussion.
7.
Clarification
of a number of points under product availability was necessary. These related
to the list of diseases absent from the EU, the impact of export policy on
disease control, the need for more emphasis on vaccination to control diseases
and the change in emphasis in new EU legislation on the role of vaccination to
control diseases such as Avian Influenza and FMD. Research into the way in
which vaccination could be integrated into control measures would be important
with the changing emphasis.
8.
A
table in the draft SRA listed diseases and availability of products. It was
emphasised that any such tables should be constructed in such a way as to avoid
any confusion. It was also suggested that selection for disease resistance
should be included in the draft although it was pointed out that a separate
technology platform was dealing with animal breeding.
Prioritisation.
9.
A
brief discussion on prioritisation of diseases concluded that it was extremely
difficult to allocate diseases into a simple classification as many factors had
to be considered. These include whether the disease was an EU or Global
problem, the variation in importance around Europe, parasitic diseases
especially with the development of resistance and the lack of vaccines. A
mechanism for including impact of societal views and the high individual cost
for some disease had to be developed. Disease prioritisation can also change
with events both within and outside the EU. For many diseases, the tools for
control do not exist making the problems difficult to tackle. It may be
possible to produce a list of diseases and to identify those for which
solutions will be found in the near future and others where the solution will
be in the mid or long term. Prioritisation of diseases should be the subject of
research.
10.
It was
concluded that prioritisation with the large number of variables would be very
difficult to develop and agree. This would take time and effort. In the short
term it would be more appropriate to list diseases of concern to Europe. It was
also agreed that a list of diseases which posed a potential threat to Europe through
bio-terrorism should be included in the SRA. The members of the group would
email the secretariat with their list of potential diseases.
Basic Research
11.
Clarity
is required in the draft SRA concerning the proposal for a collaborating centre
for epidemiology. There was an agreed need to avoid additional administration
and bureaucracy. A virtual centre would be more acceptable.
Technology Transfer
12.
This
was not within the remit of the working group.
Regulatory issues
13.
The
consensus of the meeting was that much had been achieved in Europe over the
past 25 years and that the initial draft of the SRA was too negative. It was
agreed that the following wording should be inserted into the chapter, “The
development of the regulatory requirements over the past years had resulted in
the improvement of products, food safety and a more harmonised regulatory
approach throughout the 25 Member States”. It was important to undertake
research in order to find technical solutions to the current barriers.
14.
The
question of antigenic drift was discussed. In the case of equine influenza, the
laboratories work together to review strains and publish an annual list of
strains recommended for inclusion in vaccines. Unfortunately this is too late
for the industry as the system will not allow a quick change to new vaccine
strains. The system works more efficiently in the case of human influenza
mainly because testing for extraneous agents is undertaken centrally and the
tested strains released to the industry. This follows the CHMP guidelines. On
the veterinary side, little is done before the animal health industry obtains
the new and untested strains. Overcoming the problems of testing seed strains
is a major issue but not one which requires research. The methodology for
testing and strain purification is defined in the European Pharmacopoeia. It is
important that those in the laboratories and technical research areas
understand the importance of testing for the extraneous agents and in providing
tested strains to the vaccine manufacturers at the earliest possible time.
15.
The
development of vaccine antigen master files has become a problem with different
views held by member states. It is important to differentiate technical
concerns from administrative, political and general concerns. This is a
potential barrier and a survey to identify the detail of the technical concerns
could result in the requirement for research to resolve the technical problems.
16.
Considerable
concern was expressed that the same rules were being applied to human medicines
as were applied to veterinary medicines. There was a need to differentiate the
human and veterinary regulatory systems especially as in recent debates in the
European Parliament there was much less
debate on the proposed legislation for veterinary regulation. The drivers for
human regulation are quite different. A research programme into the drivers for
the regulation of veterinary medicine, a comparison of those for human
medicines and an understanding of the mechanisms involved could lead to the
development of more specific targeted legislation which could have many
advantages for Europe, especially the facilitation of authorisation of
veterinary medicines.
17.
Within
Europe a major objective in animal welfare is to reduce the use of animals in
testing programmes for chemicals and medicines. Considerable importance is
attached to this objective. This means wherever possible a reduction in animal
testing requirements and the replacement of animal challenge testing. This
could be achieved in a number of ways by having strict guidelines on efficacy
testing, reducing the requirements for testing for efficacy and quality and
identifying alternative technologies or new methods for providing assurances on
safety, quality and efficacy of veterinary medicines. Extensive research is
needed in this area.
18.
For all
diagnostic tests there are regulatory controls in the USA and in Europe for the
human diagnostic tests. In Europe this is not the case for the diagnostic tests
used in the veterinary field. The OIE has developed a validation process for
diagnostic tests but it was not clear whether Europe would accept the process
or demand additional testing to validate the tests in a European context. In
the US authorities recheck tests on the grounds that checking under the
epidemiological and field conditions related to their situation is essential.
The working group considered that diagnostic tests must be validated but
whether this should be by the OIE alone or whether the EU should have a system
similar to the US needed more thought.
The OIE system was well advanced and could provide the basis for an
approval system. However, the opinion of DG SANCO would be needed as the
responsibility for the use of tests to assist in the control of disease fell
within their area of responsibility. As with the development of medicines it
was important that those developing new diagnostic tests were aware of the need
to collect appropriate data to validate the tests.
19.
A range
of formal guidelines, produced by the CVMP, exist. These provide guidance to
the industry on procedures and requirements for testing of safety, quality and
efficacy of veterinary medicines. In
many cases the guidance has almost the same status as legislation. Monographs are
also produced which act as guidance. It would be valuable to undertake a review
of the guidelines not only of their content and their relevance but also of the
impact and benefit which the guidelines deliver. Much depends of the
interpretation of the guidelines by those using them. No research has been
undertaken into the value of guidelines or ways in which they could be improved
if they are not meeting the needs of the regulators or the industry.
20.
A
number of other possible research areas were discussed and included:
Conclusions
21.
Professor
Scudamore summarised the provisional conclusions of the working group. A number
of important changes were needed to the draft SRA. It was important to build on
the regulatory process and to ensure that the best risk based regulation
existed in Europe. There were a number of important issues which resulted in
barriers to the development and delivery of new tools for the control of major
diseases.
22.
The
most important areas for research or survey identified by the working group
were:
An assessment of the different drivers for
regulation in the veterinary medicine as compared to human medicines
Research into the value, use, impact and
problems with the Guidelines issued to the industry in an attempt to interpret
the legislation
Development of a risk based model to define
risks and benefits from veterinary medicines and to use the model to make risk
based decisions and determine the testing required for new products.
Coordinated action to study the work that is
carried out in Europe in order to build a database of research throughout the
EU and to maintain and publish such a database.
23. Other
areas for consideration for the SRA which had emerged during the discussion
included:
Identify the technical issues related to antigen
vaccine banks
Detailed understanding of antigenic variation
and the impact on authorisations
Reduction of animal testing by either using
alternative methods or reducing the testing needed
Research on the factors that influence the
acceptability of new technologies to society
Work Plan
24. The following work plan was agreed:
Circulate
the notes of this meeting to all participants for their comment/agreement
within 2-3 weeks
Produce
a revised Strategic Research Agenda incorporating the working group
discussion and conclusions for discussion by the chairman of the 3 working
groups meeting with the secretariat on 20 December 2005.
A
revised Strategic Research Agenda to be circulated to all
working group members for comment and revision in early January 2006.
Further
revised version of the SRA to be sent to all stakeholders for comment and
discussion at a stakeholder meeting on 15 February.