Minutes of the 27th Regulatory Procedures AHG

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DISCONTOOLS Chair & Vice-Chair meeting
Tuesday, 13th January 2009
at the offices of IFAH-Europe
Rue Defacqz 1, 1000, Brussels
LIST OF PARTICIPANTS
Members:
Invited:
FLI / Thomas METTENLEITER
VWA/EMIDA ERA-Net / Wim OOMS
MERIAL / Carolin SCHUMACHER
IZSVe / Stefano MARANGON
PFIZER / Jeremy SALT
DISCONTOOLS / Declan O’BRIEN
DISCONTOOLS / Morgane DELAVERGNE
IFAH-Europe / Jim SCUDAMORE (Consultant)
DG RESEARCH / Isabel MINGUEZ-TUDELA
DG RESEARCH / Gearoid SAYERS
Apologies :
OIE / Elizabeth ERLACHER-VINDEL
AGENDA
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Introductions
Overview of all Working Packages
Timeline of note in 2009
WP2 – review of Minutes and Actions agreed
WP3 – review of Minutes and Actions agreed
WP4 – review of Minutes and Actions agreed
Review and ongoing management of areas of overlap
Update on Actions for each WP
Review of membership of each WP
Website progress
AOB
DISCUSSION
1.
Introductions
The agenda was approved with the addition of a discussion on the updated scoring model
under point 4.
2.
Overview of all Working Packages (WPs)
MD gave a short presentation summarising the objectives, the work and the ongoing
actions of all WPs (attached).
3.
Timelines of note in 2009
MD presented the actions accomplished or still ongoing for 2008 (attached). The first
Interim Board meeting was held in May 2008 and the first WPs meetings in November
2008. The Stakeholder Forum and the Advisory Council did not meet this year but a joint
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meeting will be organised in July 2009. The website should be activated in March 2009 and
dates are already agreed for the second WPs meetings in March 2009.
4.
WP2 – review of Minutes and Actions agreed
TM gave an overview of the first WP2 meeting held in Brussels on the 20 th October 2008.
He explained the different models presented on the day by DG SANCO, Defra, RIVM and
the ETPGAH.
At the WP2 meeting, discussions included possible overlaps of the DISCONTOOLS with the
OIE study commissioned by DG SANCO. DOB stated that the DISCONTOOLS work is riskassessment orientated, whereas the OIE study includes many elements of riskmanagement. The presentation from RIVM highlighted the risk that a model may make it
quite easy to separate the first and last five diseases in a priority list, but that it may be
quite difficult to rank those in between.
Given the amount of information presented, TM stated that it was difficult to draw
conclusions at the meeting in relation to what could be achieved, how to avoid overlap and
how to work in a complimentary manner.
On discussion, the Chairs and Vice-Chairs agreed that the DISCONTOOLS model should be
kept as simple and flexible as possible, taking into account the views from all stakeholders
involved in the project.
On discussing the revised model that had been circulated before the meeting, it was agreed
that good progress had been made on the scoring system and it was decided to test the
model on 6 diseases (RVF, FMD, BTV, AI, Mastitis and Rinderpest). We should invite a
number of experts to provide feedback on each disease and then compare consistency in
the scoring. We could then decide if 5 levels for scoring are appropriate (ranging from 1 to
5 and -2 to +2) and on any other changes that need to be made. Under the control
measures heading, it was agreed to extend the criteria by separating the products
(vaccination tools, diagnostic tools and pharmaceutical tools) and by creating criteria on
availability, prevention and control, strategic reserve, capacity of production, market
potential, cost, quality and efficacy.
JS undertook to propose text for each cell in the revised model.
The work of DISCONTOOLS centres on prioritisation of research to develop tools or better
tools to control priority diseases. The OIE work on prioritisation includes elements of risk
management such as those related to resource allocation, legislative development, where
to use tools, capacity and will assist a risk manager in taking decisions.
Action: MD to send a proposal to CS (vaccines), Johanna Koolen (diagnostics) and
Jeremy Salt (pharmaceuticals) to provide input on the appropriateness of the
criteria for the different types of products. JS to propose text for cells.
5.
WP3 – review of Minutes and Actions agreed
CS referred to the objectives of WP3 which are to identify gaps in knowledge and products,
direct research towards gaps, establish a methodology to do Gap Analysis and to propose
solutions to fill the gaps. Gaps may include regulatory factors.
At the meeting of WP3, it was clear that relatively few people have expertise in Gap
Analysis. Work on sourcing vaccines has been carried out in Australia and the University of
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Ames have a good database. An analysis in the US concluded that overlap exists and that
vaccine production capacity is too low to cope with a sudden surge in need.
It was clear that databases exist in relation to the availability of vaccines on a global basis
but actual availability would have to be checked (production may have stopped, be very
limited, etc.). In the case of diagnostics, very little information is available.
In discussing the way forward, the Chairs and Vice-Chairs agreed on the need to focus on
Knowledge, Diagnostic and Vaccine gaps. Concerning vaccines, it was agreed that we need
to define possibly 10 criteria that make up the ideal vaccine. A gap could then be quantified
and the research need specified. Similar criteria would need to be developed for knowledge
and diagnostics. It was agreed that we should refine the Gap Analysis part of the
information gathering questionnaire and test out the methodology on a disease
(Knowledge, Diagnostic and Vaccine gaps). Having defined the model more clearly, we
would move to ranking the gaps, providing the information to WP2 and then seek feedback.
It was agreed that we should work on AI as an example and IMT agreed to ask some RVF
experts to provide feedback on the questionnaire. CS noted that we lack information in
relation to ASF immunology and this should emerge as a knowledge gap.
Action: Secretariat to propose Gap Analysis questionnaire reflecting the
discussion and test it with experts.
6.
WP4 – review of Minutes and Actions agreed
For this Working Package, JS provided a detailed presentation on the objectives and the
ongoing work of the group. A number of presentations were made from the pharmaceutical
industry, OIE, diagnostics industry, academia and the public sector. JS noted that no
blueprints exist for detecting new technologies and that it would be necessary to develop a
methodology for technology scanning. The group agreed to seek presentations from other
industries such as human medicine, water industries, food industries, mobile telephone
technology and space technologies as a means of investigating if blueprints for detecting
new technologies exist in other sectors. Communication issues were also discussed.
Action: Secretariat to organise presentations from other industries.
7.
Review and ongoing management of areas of overlap
DOB presented the main overlap
(attached). It was noted that all of
and that all potential overlaps had
agreed. CS stated that an efficient
synergistically.
8.
that could be encountered between the three WPs
these matters had been discussed during the meeting
been identified and coordination processes had been
coordination is essential and that the WP’s can work
Update on Actions for each WP (attached)
This relevant action points had been discussed during the presentations from each WP.
Proactive involvement of the participants in the implementation of the actions is required to
ensure implementation. A lot of action is ongoing and it was noted that ongoing effort
would be required to achieve our objectives over the four-year lifespan of the project.
9.
Review of membership of each WP
MD presented the list of participants for the three WP’s. WP2 is already a large group with
more than 40 members but it was agreed to pursue a representation from UECBV. WP3 is
appropriate in size and has a good representation of stakeholders. Regarding WP4 it was
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agreed that some more representation from the diagnostics industry, biotechnology
industry, academia and the human pharmaceutical sector would be beneficial.
Action: IMT to provide some contact details.
10. Website progress
DOB presented an update on the web development (attached). The public website and its
member area should be available in late-February and the database in March 2009. The
secretariat has attempted to foresee all the requirements for building a flexible searchable
database and the output will be presented in the form of a disease database, scoring
criteria and prioritisation model.
11. AOB
 Date for the next meeting: July 9th 2009, at 9:00 (Brussels time).
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