|
A EUROPEAN TECHNOLOGY PLATFORM |
Working
Group 3 “Horizontal Issues” - Report
Brussels,
13 October 2005
Final, 7 November 2005
|
HMA
UK / S. Dean (Chair) IFAH
/ P. Jones (Vice-chair) European
Commission / B. Arbelot BBSRC
/ P-P. Pastoret BBSRC
/ D. McKay 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 / A. Rodolakis Intervet / M. Gravendijck |
Liverpool University / J.
Scudamore (minutes) OIE / Ch. Bruschke OIE
/ S. Edwards Pfizer / A. Peters Universidade Técnica Lisboa / T. Fernandes IFAH-Europe / D. O’Brien IFAH-Europe / H. Marion Apologies European Pharmacopoeia / P. Castle Merial / J. Lechenet |
Agenda
Emerging and existing diseases
- C. Bruschke
Barriers to development of new tools
- R Banks
Societal acceptance of technology - M
Weijtens
Research Proposals
Minutes
1. The first meeting of the working group
was held at the COPA-COGECA offices on Thursday 13 October 2005. A total of 18
participants attended.
2. Mr D O’Brien, Managing Director of
IFAH-Europe who is the Chairman of the Steering Council for the platform, welcomed the
participants. He explained that the platform had a wide range of stakeholders.
It had an important role to play in the development of the research environment
for the next decade especially in the control of animal disease of major
importance. He also thanked COPA/COGECA for their hospitality in providing the
meeting facilities, DG Research of the European Commission, the Presenters and
Participants.
3. Professor Jim Scudamore provided an update on the
development of the ETPGAH. Full details of his presentation are available as a
PowerPoint presentation (available on the website referenced at paragraph 7).
He described the background to the technology platforms and summarised the
current status of platforms generally. Stage one in the development of the
ETPGAH is now completed with the final vision of the platform on the web and
due for publication in the next weeks. This defines the scope for the Strategic
Research Agenda (SRA) and will assist in forming the structure and focus of the
SRA. The EU Commission in developing their framework 7 work programme will draw
on the SRA developed by the industry led platform.
4. Three working groups had been established of which this
group would be working on Horizontal issues.
Working group 1 would deal with basic research and mapping and working
group 2 would cover technology transfer and interchange.
5. The first meeting of the working groups would be a
brainstorming session, which would seek to identify the challenges to be met in
converting the vision into a Strategic Research Agenda. The second meeting of
the groups would seek to draft a SRA, which would then be provided to all the
stakeholders for comment before being finalised.
6. In order to focus the discussions a series of presentations
were given during the morning. Each of the presentations was followed by
discussion. In his introduction the chairman, Steve Dean said that the
presentations and subsequent discussions would provide the basis for the work
of the group during the afternoon.
7. The three comprehensive presentations covered a wide range
of horizontal issues and needs. Details of the presentations are on the ETPGAH
web site at http://www.ifah.be/europe/euplatform/platform.htm.
Each presentation stimulated discussion and the comments, which are summarised
in the paragraphs below.
Emerging and existing
diseases. C. Bruschke.
8. The presentation raised many queries in particular the
problem of funding for vaccine development and delivery especially in developing
countries. Cheaper marker vaccines were required but without the appropriate
price the vaccines could not be used in developing countries where the disease
was endemic. Pen-side tests were required for speed of diagnosis and for use in
countries where there was a problem with poor laboratory facilities. The
question whether farmers, vets, or official vets were authorised to use the
pen-side tests was important. In the case of pen-side tests they should be well
characterised, validated and fit for purpose.
9. The presentation had concentrated on viruses but bacterial
diseases were also important in the context of public health. The societal
benefits of vaccines further down the food chain ultimately at the consumers
level should be assessed and incorporated into the cost and benefits of using
vaccines in animals. The benefits of salmonella vaccine in poultry reducing
food contamination and ultimately human infection should be quantified. There
are still gaps in the fundamental understanding of the zoonoses in particular
basic epidemiology, immunology and potential control measures using competitive
exclusion or bacterial phages.
10. One of the major issues for Europe is the availability of
research facilities to undertake research on high risk organisms. The problem
is not financing the building of the facilities but in the cost of funding the
maintenance and use of the buildings. More coordination is needed between
countries to avoid duplication. Sharing these facilities with industry could
also be considered.
11. Other areas for research included the use and development of
anti-virals, the potential for developing immuno-stimulants as boosters of the
immune system, marker vaccines, DIVA (Differentiate Vaccinated and Infected
Animals) tests and methods for discriminating infected from vaccinated animals.
12. Participants also
recognised that there is a significant difference between the market for
veterinary vaccines and human vaccines. In particular where there seems to be a
greater commitment on the part of the human pharmaceutical industry to develop
new vaccines, the ROI on veterinary vaccines is far less because of the
fragmentation of the market and the absence of any subsidies from government
funds because there are no national health systems for veterinary medicine in
the EU. Therefore the delegates recommend that some thought be given to the
possibility of state funding for vaccine development and registration for these
important veterinary diseases which is in synchrony very much with the objectives
of the 7th research framework programme.
Barriers to the development
of new tools. R.
Banks.
13. The quantity of data required for the efficacy evaluation by
the regulatory authorities in Europe prior to authorisation of the product was
considered to be an issue to be followed up. The question was raised whether
efficacy data requirements might be reduced with a greater reliance on
post-authorisation safety monitoring according to Pharmacovigilance
requirements therefore reducing the initial data required for authorisation. It
was not always clear whether the quantity of efficacy data provided to the
regulator provided added value in relation to the costs of generating the data
from field and other trials. Field studies after the release of a compound
could provide useful information. Because the requirements for dose titration
and dose confirmation studies are often very extensive this provides for
considerable amounts of investment having to be made into the development
programme and it was suggested that consideration be given to a greater
reliance from field studies after the release of a compound to provide the
necessary efficacy data.
13. The example of the development and authorisation of the West
Nile Fever vaccine in the USA demonstrated that the industry could in some
circumstances react very quickly. A benchmark review of the situation in the
USA compared to Europe would be of use to identify the similarities and
difference in the regulatory procedures. Two areas especially highlighted were
GMP and the efficacy data required by the US regulators in order to authorise a
product. The last sentence needs some clarification. The point that was made
is that the requirements for GMP and efficacy data are less than that in the EU
thereby facilitating easier and faster authorisation in the US and that the
benchmarking study would elaborate whether in fact this is the case.
14. Changing the antigen in a vaccine to adapt vaccination to
antigenic change in pathogens requires a resubmission of a full dossier even
though the change relates only to the initial seed strain or virus and not in
the manufacturing process. This was not required in the case of human influenza
vaccines but created unnecessary complications in the case of animal vaccines
where there was considerable antigenic variation in the virus. (eg FMD,
Bluetongue, Avian influenza.). From a vaccine production perspective the
ability to exchange one strain for another provided the seed strain was
correctly evaluated would improve the rate at which the new vaccines could be
authorised and reduce costs. Novel ways of addressing this problem were needed
such as developing an approved antigen bank of seed strains any one of which
could be used without the need to revise the manufacturing procedures or obtain
new authorisations. However it should be recognised that there appears to be
disjoint amongst the network of laboratories testing for equine influenza than
there is for the human equivalent which is why the Commission has not to date been
happy to follow the human line with a simple variation requirement. There was
also a major contrast between the requirements of the regulators and that of
the animal health authorities who when faced with an outbreak of disease where
a vaccine was urgently required for control purposes could issue an emergency
authorisation.
15. At present much of the basic information on a disease and the
pathogen was not fully understood.
Basic research was still needed in many areas. Historically when
approaching the authorisation of a product the regulators had evaluated risk
alone with little or no assessment of the benefits. Research was needed into
the way in which the risk/benefit component could be incorporated into the
process. There was a general view that there should be closer links and
networks between the research workers and the industry with the development of
centres of excellence.
Societal acceptance of
technology. M. Weijtens
16. Much of the discussion centred around the need to understand
public perception, risk communication and societal views on a range of issues
such as risk, benefits, genetically based products and the seemingly large
information gaps which exist between public perception and the situation in
reality. One such topic related to the
public perception of the vaccination of food animals for disease control
purposes. Good vaccines and tools were needed but the retailers could in some
circumstances require the products from these animals to be labelled and to be
traceable.
17. The animal health industry was well aware of the regulations
in place but academics often carried out research with little understanding of
the Intellectual Property (IP) issues involved or the potential use of their
discoveries. It was considered important that research scientists should be
encouraged to understand the importance of IP and to assess the potential
future use of their discoveries.
18. In many countries there is a free unregulated market in
veterinary diagnostic tests. However in Germany and the US diagnostic kits are
subject to regulation as are the medical diagnostic kits used throughout the
EU. A diagnostic test validation procedure has recently been introduced by the
OIE which sets standards but is not a regulator. The registration will be based
on a comprehensive validation using a template requiring a dossier of
information from the company seeking registration. The OIE registration will be
based on the concept of fit for purpose which will relate to sensitivity and
specificity of the test and whether it
is to be used for screening or confirmation of disease. Whilst
attendants appreciated the benefits of the OIE validation scheme, some concern
was expressed that such a scheme does not acknowledge the different field and
epidemiological influences that can exist on a regional basis. It was proposed
that a better means of assessing the suitability of such test would be through
a regulatory procedure. In the European Union there is such a directive for
human diagnostic test and it was recognised that this should be facilitated on
the veterinary side as well.
19. During the afternoon the conclusions and summaries from the
morning session were discussed in order to identify the challenges for the
Strategic Research Agenda.
20. Professor Scudamore summarised the provisional conclusions of
the working group. He indicated that the conclusions from the 3 working groups
would be brought together to form the basis of the draft Strategic Research
Agenda which would be available for the next meeting. He reminded the working
group of their terms of reference:
21. The difficulty would be in translating the discussion of the
working group into a Strategic Research Agenda. It was important to clearly
identify at the top level the main challenges facing the ETPGAH. If there were
too many challenges the SRA would loose its impact. It was important to start
with the main challenges and then to identify the general topics or initiatives
at the next level. Finally the specific details could be worked out but this
may be more appropriate as ongoing work for the platform. This detail could be
included as annexes or separate documents to the Strategic Research Agenda at a
later stage.
22. From the discussion 6 major challenges became apparent. These
are listed below:
23. At the general level the need for detailed initiatives were
identified in the following areas:
24.
Finally,
the specific detail was considered at the level of research and disease
priorities. A wide range of suggestions were made and included:
Producing the SRA: Work Plan
25. The following work plan was agreed by the
working group:-
Within 2 weeks to send any comments to Steve Dean and IFAH for inclusion
in the notes of the meeting.
Aim to place presentations on the web site within 2 weeks provided
presenters indicated their agreement or provide an alternative shortened
version.
Circulate the notes of this meeting to all participants for their
comment/agreement within 2-3 weeks.
Produce a draft Strategic Research Agenda incorporating the working
group discussion and conclusions for the next meeting.
Agree on a further version of the Strategic Research Agenda after the November meeting
which would then be circulated to stakeholders in January 2006.
26.
The
next meeting of the working group on horizontal issues would be held in Brussels
on Friday 2 December 2005.