European Technology Platform for Global Animal Health · PDF fileEuropean Technology Platform...

European Technology Platformfor Global Animal Health

Vision 2015

Kaft 07-12-2005 11:47 Pagina 1

1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8

ContentsForeword 3

Group of Organisations 4

Signatories Global Animal Health: Vision 2015 6

Executive summary 9

1. The Need for Vaccines, Pharmaceuticals and Diagnostic Tests 121.1 A Global Problem 121.2 Impact of Animal Disease 121.3 Control measures 131.4 Vaccines 131.5 Diagnostic tests 141.6 Pharmaceuticals and Biocides 151.7 Conclusions 15

2. The Development of Vaccines, Pharmaceuticals and Diagnostic Tests 162.1 Technological advances 162.2 Research Position 162.3 Industry Perspectives 172.4 Regulatory Aspects: Vaccines 192.5 Regulatory Aspects: Diagnostic Tests 202.6 Regulatory Aspects: Pharmaceuticals 202.7 Conclusions 20

3. Developing a Vision for 2015: From Innovation to Delivery 21 3.1 A European Technology Platform 213.2 European Objectives 213.3 Meeting the Challenges 213.4 Research Policy 213.5 Global Dimension 223.6 Interdisciplinary Research 233.7 Intellectual Property Rights (IP) 233.8 Industry: Manufacture and Production 233.9 Regulatory Aspects 243.10 Conclusion 24

4. The Way Forward: Developing a Technology Platform 254.1 Partnerships 254.2 Main activities 254.3 Platform Organisation 264.4 Outline for the Strategic Research Agenda 274.5 Roadmap and Milestones 27

Opmaak brochure corps 10 08-12-2005 12:10 Pagina 1

1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8

Foreword

Foreword by Janez POTOCNIKCommissioner for Science and Research

Major animal infectious diseases can have devastating social and economic impacts in both developed anddeveloping countries.

The recent cases of foot-and-mouth, classical swine fever and the current outbreak of avian influenza areprime examples. The latter is an immediate threat to the livelihood of subsistence farmers and industrial pro-duction in the region. On a global scale however, a much greater threat looms that of a human pandemic,which risks to kill millions of people and to disrupt the political and economic stability of countless countries.

The creation of the European Technology Platform for Global Animal Health represents an additional efforthelping to fight against the spread of such diseases. Through bringing together all the relevant stakeholders,a Strategic Research Agenda will be developed whose implementation will concentrate efforts in the medi-um to long term on those issues where scientific breakthroughs are needed.

Together with my colleagues Vice-President Verheugen and Commissioners Kyprianou, Michel and FischerBoel, I wish to thank the European arm of the International Federation for Animal Health for taking the ini-tiative to launch this platform with a truly international dimension. Not only are all the main players at aEuropean level being brought together but also the key international organisations working in this vital field.Moreover, a number of third countries are also participating.

This vision paper constitutes the first milestone in the work of this technology platform and a sound basis tomove forward.

I wish everyone involved in Global Animal Health the best of success.

v


Group of Organisations

AEFRV Nadia PLANTIER, Interim President of AEFRV

BBSRC Julia GOODFELLOW, Chief Executive of BBSRC

CEVA santé animale Philippe du MESNIL, Chairman & CEO of CEVA santé animale

CIDC-Lelystad, EPIZONE Piet A.van RIJNCoordinator of Network of Excellence “EPIZONE”

CIRAD, EDEN Emmanuel CAMUS, Director, EMVT Department of CIRAD, EDEN

COPA Rudolf SCHWARZBÖCK, President of COPA

COGECA Eduardo BAAMONDE, President of COGECA

CVO Denmark Preben WILLEBERG, Chief Veterinary Officer (CVO) of theDenmark

CVO France Monique ELOIT, CVO of the France

CVO Netherlands Peter W. de LEEUW, CVO of the Netherlands

CVO Slovakia Jozef BIRES, CVO of the Slovakia

EAEVE Marcel WANNER, President of EAEVE

EMEA Peter JONES, Head of Unit Veterinary Medicines and InspectionEMEA

ESVV Peter NETTLETON, President of ESVV

1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8


EuropaBio Johan VANHEMELRIJCK, Secretary General of EuropaBio

Facultad de veterinaria, Carmen ACEBAL SARABIA, Vicerrectora de Investigación of the Universidad Madrid veterinarian faculty, University of Madrid

FAO Joseph DOMENECH, FAO Chief Veterinary OfficerChief, Animal Health Service

FVE Tjeerd JORNA, President of FVE

GALV Ian MAUDLIN, Implementing Director of GALV

Head of the Medicine Agencies Steve DEAN, UK Presidency of the HMA

IAH, CA FMD/CSF Martin W. SHIRLEY, Acting Director of IAH, CA FMD/CSF

IABs Paul Pierre PASTORET, IABs Representative

IFAH - Europe Brian CLARK, Chairman of IFAH-Europe

ILRI John McDERMOTT, Deputy Director General Research of ILRI

Intervet Ruurd STOLP, President Intervet International b,v

MED-VET-NET André JESTIN, Coordinator of MED-VET-NET

Merial Jerry BELLE, CEO of Merial

OIE Bernard VALLAT, Director General of OIE

Vakzine Projekt Management Albrecht LÄUFER, CEO of Vakzine Projekt Management

1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8


Signatories Global Animal Health: Vision 2015

1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8

Peter W. de LEEUW CVO Netherlands

Eduardo BAAMONDECOGECA

Preben WILLEBERGCVO Denmark

Monique ELOITCVO France

Piet A. van RIJNEPIZONE

Emmanuel CAMUSCIRAD, EDEN

Rudolf SCHWARZBÖCKCOPA

Nadia PLANTIERInterim President - AEFRV

Julia GOODFELLOWBBSRC

Philippe du MESNILCEVA Santé Animale

Jozef BIRESCVO Slovakia

Marcel WANNEREAEVE


1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8

Paul-Pierre PASTORETIABs

Ian MAUDLINGALV

Steve DEANHeads of Medicines Agencies -

Veterinary (HMA-V)Martin W. SHIRLEYIAH, CA FMD/CSF

Carmen ACEBAL SARABIAUniversidad Madrid

Joseph DOMENECHFAO

Tjeerd JORNAFVE

Peter JONESEMEA

Peter NETTLETONESVV

Johan VANHEMELRIJCKEuropaBio

Brian CLARKIFAH-Europe

John McDERMOTTILRI


1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8

Bernard VALLATOIE

Albrecht LÄUFERVakzine Projekt Management

GmbH

Ruurd STOLPIntervet

André JESTINMED-VET-NET

Jerry BELLEMERIAL


Outbreaks of major animal diseasessuch as Bovine SpongiformEncephalopathy (BSE), Foot andMouth disease, Classical Swine Fever,Avian Influenza, Bluetongue andWest Nile Fever can have a devast-ating impact on animal and humanhealth, food safety, the wider econo-my, the countryside, animal welfare,rural communities and the environ-ment. Europe cannot be isolated fromworld events and any actions to redu-ce or eradicate disease agents world-wide will be to the benefit of all.

Effective tools for controlling animaldiseases of major social and economicimportance are vital not only forEurope but also for the rest of theworld. The control of infectious andcontagious disease can be complexwith education, training, zoosanitaryand other hygienic measures havingan important role to play.Epidemiological assessments, econo-mic evaluations and risk analysis arepart of the approaches, which can beadopted and for which research con-tinues to be required. In the longerterm breeding for resistance may havean important role to play in diseasecontrol.

However the use of vaccines and dia-gnostic tests are a key component asthey have the potential to support con-trol and eradication and to be highlycost effective. At present there are noantiviral drugs for use against themajor viral diseases of animals.Consequently, vaccines and diagnos-tic tools are often the only solutionavailable for control. Whilst all toolsneed to be considered the technology

platform concentrates on the develop-ment and delivery of vaccines and dia-gnostic tests in the first instance.

Europe has been at the forefront ofadvances in genomics and biotechno-logy over the past decade. Theseadvances provide opportunities todevelop new or improved vaccinesand diagnostic tests against major ani-mal diseases. The pace of scientificprogress continues to increase andEurope must continue to use theopportunities presented by the newtechnologies to retain its competitiveposition. However, the advancedresearch needed to develop new pro-ducts is expensive in terms of experti-se, equipment and facilities.

The animal health industry has crea-ted significant socio-economic bene-fits for Europe, but it must remaincompetitive if it is to survive. At pre-sent several factors threaten the indus-try’s short- and long-term competitive-ness. They include the EuropeanRegulatory Framework within whichit has to operate, the small size of themarket segment and the increaseddevelopment time and costs for newproducts. The industry’s future suc-cess depends on the ability of compa-nies to launch and exploit innovativeproducts not only for farm animals butalso for companion animals.

The investment by the European ani-mal health industry in research anddevelopment (R&D) is nearly 10% ofits turnover. (The average is 12% ofturnover for multinationals and 6% forsmall- and medium-sized enterprises.)However, in 2002 the percentage of

that R&D budget that was defensive –spent on keeping existing products onthe market – was 35% in Europe com-pared to 16–18% in the USA.Nevertheless the recent pharmaceuti-cal legislation in Europe adopted inMarch 2004 has to be implemented inthe EU Member States by the end of2005. This new legal frameworkincludes improvements in the timingof authorisation procedures and theremoval of renewal requirements the-reby reducing the costs of defensiveresearch significantly.

The delivery of new or improvedveterinary medicines (this term inclu-des veterinary vaccines and veterinarypharmaceuticals) and diagnostic testsis a high-risk business that uses manydifferent approaches. Europe current-ly has a relatively good scientificresearch base from which to takeadvantage of the new genomics andtechnologies but the translation ofscientific discoveries into authorisedveterinary medicines (vaccines orpharmaceuticals) and diagnostic testsneeds to be significantly improved.

This is due to a range of factors inclu-ding economic, regulatory and socialissues. Economic issues such as cost,price, competition and potential ear-nings are particularly relevant for vac-cines and diagnostics for epidemic ani-mal diseases. Regulatory and socialissues compound the problem byincluding ethical considerations.Costs for development can be highand, in the case of epidemic animaldiseases, include the costs of contain-ment facilities to meet the require-ments for authorisation. Delay in rea-

1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8

Executive Summary


ching a financial break-even point andmaking a profit may act as a furtherdisincentive to the involvement of pri-vatesector companies.

These delays are a central problem asthe market in Europe for products lin-ked to major epidemic diseases issmall. In developing countries the pro-blem is compounded by the inabilityof poor farmers to pay for these inter-ventions and the concomitant need touse public resources to control epide-mic diseases.

A similar problem is encountered inthe generating of sufficient interest inthe development of products forminor use or in minor species. A newand innovative approach is needed tofund the research, development anddelivery of products be they vaccines,pharmaceuticals or diagnostic tests.

There is an urgent need to boostresearch by developing mechanisms toprioritise requirements and developmore effective funding, so that new orimproved veterinary medicines - vac-

cines and pharmaceuticals - and dia-gnostic tests can be delivered. Closelyassociated is the effort required toensure the effective transfer of innova-tions and breakthroughs from theresearch base into the development,manufacture, authorisation and distri-bution of new and safe products forpractical use. There are many chal-lenges to be overcome if new pro-ducts are to become available, especi-ally as this is an area where the returnin terms of financial profit may be lowbut where the social, economic,public health and environmental gainscould be high.

For these reasons a “EuropeanTechnology Platform for GlobalAnimal Health” was launched underthe leadership of the industry. TheTechnology Platform will provide amechanism for focusing research thatdelivers new tools for the control ofmajor animal diseases be they vacci-nes, pharmaceuticals or diagnostictests. Consequently it will contributeto overcome the constraints on thesuccessful development and delivery

of products for minor animal speciesor minor use in major and minor spe-cies.

The aim of the Technology Platformis:

• To facilitate and accelerate thedevelopment and distribution ofthe most effective tools for control-ling animal diseases of majorimportance to Europe and the restof the world, thereby improvinghuman and animal health, foodsafety and quality, animal welfare,and market access, contributing toachieving the Millennium Deve-lopment Goals.

The strategic objectives of theTechnology Platform in this aimshould be to:

• Sustain and strengthen the researchenvironment and infrastructureneeded to support visionaryresearch into animal health and inparticular the epidemic animaldiseases and zoonoses.

• Ensure that Europe has a multi dis-ciplinary strategic research capacitywith the core expertise and facili-ties to anticipate and respondrapidly to new and emerging ani-mal diseases, including zoonoses.

• Maintain a highly competitiveindustry working in partnershipwith the research community, pro-duction stakeholders, the publicsector and regulators.

• Facilitate the efficient and rapidtransfer of discoveries into practicalapplications such as tests and vacci-nes for diagnosing and controllinganimal diseases.

• Ensure a supportive and harmoni-sed regulatory environment thatbalances risk against need, not only

1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8


for the authorisation of vaccinesand tests but also in terms of sanita-ry standards required for interna-tional trade.

• Develop global alliances with inter-national organisations and non-European countries, includingdeveloping and developed coun-tries, to enhance research, devel-opment and new product delivery.

• Improve education, training andunderstanding throughout thewhole supply chain from initialresearch through to the delivery ofnew products.

• Mobilise the public and private sec-tors in Europe to commit funds toeffective R&D activities throughpublic – private partnerships.

The Platform will bring together allthe relevant stakeholders at EU andnational levels. It will also include sta-keholders from international organisa-tions such as the Food and AgricultureOrganization of the United Nations(FAO) and the Office Internationaldes Epizooties (OIE), as well as fromnon-European countries. Substantialbenefits that will increase competitive-ness and productivity can be expectedif all the key stakeholders can be mobi-lised to work together to create andimplement a common vision.

While the European TechnologyPlatform for Global Animal Healthwill concentrate on animal diseases ofpriority for Europe, it will take intoaccount the perspectives of the globa-lised setting in which these diseasesprevail. The global nature of theseproblems and the scale and complexi-ty of new product developmentmeans that solutions will not be veryeffectively produced or very robust ifdeveloped exclusively for and/or inEurope. Alliances with non-European

countries and international organisati-ons such as OIE and FAO will beessential.

The scope of the technology platformis currently limited to terrestrial anim-als.The primary focus in this vision is thedevelopment of vaccines and diagnos-tic tests for major animal diseases butthis does not preclude the develop-ment of pharmaceuticals. The effi-cient control of a number of other ani-mal diseases is also endangeredbecause of the limited arsenal of inno-vative pharmaceuticals available inanimal health.

Multi-resistance of bacterial strainsand endo / ectoparasites against phar-maceuticals are more than a threat,but a reality. There is an urgent needto continue research and developmentof new efficient pharmaceuticals toovercome resistance to bacteria andparasites. Ruminants are not the onlyspecies concerned. New antibacterialand ecto/endoparasiticides must notbe neglected as vaccines might notalways be the most cost effective toolsand the most easy to develop.

New control methods must be foundin order to keep animals healthy, pre-vent the spread of disease, protect thepublic, improve agricultural sustaina-bility, maintain animal welfare, protectthe environment, maintain biodiversi-ty, increase security from bio-terro-rism, protect consumers of animalproducts and ensure safe supplies offood. There is a global public good fromhelping the world to address majoranimal diseases. Given the importanceof livestock to developing countries,controlling and eradicating wherepractical animal diseases will have

direct and major impacts on foodsecurity and poverty alleviation.Furthermore, the effective control ofmajor animal diseases will have a posi-tive impact in many areas of concernto society. These developments alignclosely with many EU policies in areassuch as research, animal and publichealth, the internal market with freemovement of animals and animal pro-ducts, food safety, agricultural produc-tion and incomes, development, tradewith access to markets, the environ-ment and better security from bio-ter-rorism.

As the European Technology Platformfor Global Animal Health will bedriven by the industry, short, mediumand long-term goals must be establish-ed linked to the development of vete-rinary products (vaccines, pharma-ceuticals and diagnostics), which willbe needed in the next 15 years. To besuccessful the platform must retain aspecific focus and not become distrac-ted by adopting a very wide remit. Inthe first instance the platform will dealwith major animal diseases. Howeverthe Technology Platform SteeringCouncil will consider the position andwhere appropriate will reassess priori-ties and objectives.

1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8


1.1 A Global Problem

During recent years the world has wit-nessed the emergence or re-emergen-ce of a number of major animal disea-ses. Several of these have been bothcostly and damaging; BovineSpongiform Encephalopathy (BSE),Foot and Mouth disease (FMD),Classical Swine Fever (CSF), AvianInfluenza, Bluetongue and West NileFever serve as reminders of thedevastating economic and socialimpacts animal diseases can have.

A rise in the level of international tra-vel and tourism has increased the thre-at from zoonoses and previouslyunknown diseases such as SevereAcute Respiratory Syndrome (SARS),which may originate from animals. Atthe same time more and more empha-sis is placed on the avoidance of sani-tary barriers to trade in both livestockand their products. Through this typeof globalisation diseases are reachingthe EU much more rapidly and fre-quently than before.

Worldwide there are extensive move-ments of live animals for slaughter astraders are attracted by the price diffe-rences across international borders.The majority of movements occur inthe Middle and Near East with largeand small ruminants being importedevery year. This constitutes a hazardto Southern and Eastern Europe asdiseases such as FMD and Rinderpestcan easily spread from country tocountry.

There also remain many seriousdiseases on the borders of the EU.The risks these pose to the communi-ty remains unclear but climate changemay further enhance the probability ofaccidental introduction. There is thepossibility that vectors of diseases suchas Rift Valley Fever will move intonew habitats and spread out of theirexisting areas. The potential spread ofBluetongue into new areas within theEU could result in major economicdamage to those countries with densesheep populations. Furthermore, some of these diseasesmay be used as bio-terrorism wea-pons.

Europe cannot be isolated from worldevents and any action to reduce oreradicate disease worldwide will beof benefit to all. Some diseases affectall regions of the world includingdeveloped countries, others are oftenlimited to the developing countries butwith major potential to spill over andspread to countries free of the diseaseconcerned.

1.2 Impact of AnimalDisease

Animal diseases have a major directimpact on human health. Diseasessuch as BSE, Avian Influenza,Tuberculosis (Mycobacterium bovis),Rabies and Rift Valley Fever are eitherzoonotic or potentially zoonotic, andare clearly major public as well as ani-mal health problems. Diseases such as

Brucellosis, Rift Valley Fever,Tuberculosis and Trypanosomiasiscan add to the health problems of thepoor, and in particular those with HIV/AIDS.

Moreover, it is much more difficult tocontrol diseases, especially emergingdiseases such as SARS, in an immuno-suppressed population which underli-nes the need to have a global strategy.Food safety is of critical importanceand the control of food-borne zoon-oses is of major concern to publichealth.

The introduction of a disease such asFMD or Avian Influenza into coun-tries with free trade has a devastatingeconomic, social and environmentalimpact as seen both in Europe andAsia. In the developed countries majorlivestock disease poses a threat to agri-culture, food safety, development,trade, the internal market, free move-ment of animals and their products,the environment and to national eco-nomies.

In the developing countries diseaseremains a severe constraint on devel-opment and poverty alleviation as itcurtails access to markets for livestockand products. Livestock form animportant component of the liveli-hoods of 70% of the world’s pooramounting to some 600 million peop-le. Animal diseases are a major threatto livestock-keepers and are often con-sidered to be one of the biggest con-straints to improving livelihoods. In themost marginal areas livestock often

1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8

1. The Need for Vaccines, Pharmaceuticals andDiagnostic Tests


constitute the only significant liveli-hood strategy for poor people. One ofthe most significant changes over thepast decade and for the foreseeablefuture is the increasing demand foranimal proteins to improve food quali-ty and feed an expanding world popu-lation. This is often referred to as the“livestock revolution”.

The importance of the economic bur-den resulting from endemic diseasesshould not be overlooked especially asthey pose an ongoing threat to theeconomic viability and competitive-ness of the farming industry. Thisthreat is growing with the develop-ment of resistance by nematodes, tre-matodes and external parasites to theavailable chemotherapies, which mayultimately lead to the loss of all availa-ble means to control these diseases.

1.3 Control measures

In many cases outbreaks of the majordiseases have been widespread, unex-pected, often trans national and haveseverely challenged the ability ofgovernments to control them.Experience has also demonstratedthat control measures to eradicatedisease can be very costly.

Effective disease control requiresrapid and accurate detection coupledwith a fast and effective response toan outbreak. Education and trainingare important for early detection butthe use of effective diagnostic tests forsurveillance purposes and for therapid confirmation of disease out-breaks is essential. New tests that canbe used easily by farmers in the fieldmay help to solve these difficulties butcan in themselves lead to further pro-blems if not properly applied, monito-

red and controlled by the authorities. The controls on major animal diseasesare based to a large extent on the stan-dards published by the OIE in theTerrestrial Animal Health Code. InEurope, control of diseases such asFMD, CSF and Avian Influenza hasinvolved mass slaughter of animalsinfected with the disease and the pre-cautionary slaughter of those assessedto have been in contact and potential-ly infected with the same virus.

The emergence of these diseases inEurope and Asia has led to theslaughter of millions of animals at higheconomic cost. This has given rise topublic concern that new technologicaladvances in vaccine production, dia-gnostic testing and epidemiology havenot been significantly employed. Forethical, ecological, environmental,social and economic reasons there is aneed for alternative solutions to befound for the control and eradicationof epidemic diseases.

Alternative approaches are neededwhich may supplement or replacevaccination. This is particularly true ofthe vector borne diseases whenmanagement of animal movements,vector habitats and vector life cyclecan provide effective tools. The addi-tional advantage of vector controltools is that they offer a generic appro-ach that can cover several differentinfections and viral serotype where asthe immunological approach mustinvolve specific vaccines for eachvirus/serotype and may require furtherresearch and development if the anti-genic specificity changes.

1.4 Vaccines

In the past vaccines have proved to be

effective against a range of worldwidediseases; in the long run they are themost effective and sustainable way tocombat infectious diseases, especiallyin the developing world. Successfuleradication of major animal diseaseshas been achieved in Europe throughthe combination of preventive vacci-nation and the application of appro-priate policies. In Europe, emergencyvaccination strategies and improveddiagnostic tests have also been appliedfor effective eradication or control.

Vaccines may be used prophylacticallyon a regular basis to build up flock orherd immunity so that contact with thedisease agent does not result in an out-break. This is particularly true in thedeveloping countries where an eradi-cation programme involving slaughterwould not be practical or economical-ly justified. Vaccination is also of majorinterest where wild animals are areservoir of the diseases and conse-quently hamper their control.

Vaccines may become increasinglyimportant as an alternative to thera-peutic and prophylactic use of disea-se-controlling pharmaceuticals. Thiswill have a positive impact on produc-tion and food safety by reducing or eli-minating the need for withdrawalperiods, and avoiding the presence ofresidues in foodstuffs of animal origin.As multinational companies havemoved from producing agrochemicalsto investing in plant genetics, a similartrend to use alternatives is appearingin companies that maintain animalhealth. However, there will be a longtimescale for the research and devel-opment necessary to produce vacci-nes to replace the use of antibioticsand anthelmintics.

In the UK, the Royal Society’s Report

1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8


on Infectious Disease of Livestock in2002 has summarised the followingideal characteristics for vaccines:

• Giving protection against all isolatesof the virus in all the affected spe-cies, preventing virus carriage andthe possibility of shedding andtransmission.

• Stimulating a broad level of immu-nity necessary to drive an effectiveand long-lasting immune response.

• Cheap to manufacture and simpleto administer.

• Safe to use, have long shelf life andare heat stable.

• In the case of live vaccines, aresafely attenuated and reversion tovirulence is avoided.

• Allowing discrimination betweeninfected and vaccinated animals.

• Giving good levels of maternalimmunity.

There remain scientific and develop-mental obstacles in the way of mee-ting these criteria especially with theRNA viruses. These often have manyvariants or a multiplicity of strains.They can evolve rapidly making it dif-

ficult to design long lasting vaccineseffective against all strains or variantsof the disease.

Recent outbreaks have highlighted thenecessity for not only producing newvaccines but also for improving exis-ting vaccines and providing markervaccines. A number of control pro-grammes envisage the possible use ofvaccines in combination with a “vacci-nate to live” policy. This in itself posesproblems especially in the need to dif-ferentiate infected from vaccinatedanimals, and the potential for asymp-tomatic carriers to spread disease.Unless new vaccines can be develo-ped in such a way as to avoid vaccina-ted animals being regarded as infec-ted, there is the potential for an adver-se impact on trade. The use of impro-ved diagnostic tests to differentiateinfected from vaccinated animalsbecomes increasingly important.

Vaccines do not exist for many disea-ses such as African Swine Fever, ahighly infectious disease affecting pigs.Some other vaccines could be signifi-cantly improved using newer techno-

logy. Examples include the currentvaccines for Rinderpest, Bluetongueand Avian Influenza. For some otherdiseases new instruments for deliverymay be necessary, for example, oralvaccination of stray dogs againstRabies. Currently, oral vaccines onlyexist for the wild fox population.

Vaccination is often the only practicaland realistic measure available forcontrolling endemic diseases in wild-life such as Rabies in foxes and straydogs, Classical Swine Fever (CSF) inwild boar, and Tuberculosis in bad-gers. The delivery of such vaccines tothe target species is critical for success.The Rabies control programme usinglive vaccine in baits delivered to foxeshas resulted in the eradication of thedisease in many parts of WesternEurope.

Vaccines that induce an early onset ofimmunity that results in a long durati-on of immunity are needed in the caseof emergency vaccination. The devel-opment of multivalent vaccines hasadvantages as this would reduce thenumber of inoculations to animals,reduce the handling cost and avoidanimal suffering.

1.5 Diagnostic tests

Recent outbreaks have highlighted anurgent need to improve existing dia-gnostic tests. The Report of the EUScientific Committee on AnimalHealth and Welfare in 2003 identi-fied a number of limitations to existingdiagnostic tests. In order to overcomethese problems the Committee recom-mended that there was a need todevelop:

• Methods for inexpensive and effec-

1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8


tive screening of animal products. • Simple and rapid tests (e.g. pen-

side) for use in the field, and regio-nal laboratories to support clinicalsuspicion of disease.

• Rapid and highly sensitive tests todetect animals as soon as theybecome infected.

• More sensitive and specific tests todetect infection in an individualanimal, without the need to screenthe whole herd.

• Rapid and sensitive methods fordifferential diagnosis.

There is no Community legislation forthe authorisation/licensing of diagnos-tic tests for animal health. This is a sig-nificant gap particularly with theadvent of marker vaccines, which relyentirely on the use of effective dia-gnostic tests to distinguish the immuneresponse from the field antigen to thatof the vaccine antigen. Recently theOIE developed a new procedure forvalidation of diagnostic tests in accor-dance with the Manual for DiagnosticTests and Vaccines for TerrestrialAnimals.

1.6 Pharmaceuticals andBiocides

The use of pharmaceuticals to controlanimal diseases, either in the face ofan outbreak of infection or as anadjunct to a vaccination programme,is a rationale strategy for bacterial andparasitic infections. The use of phar-maceuticals as a first line defence hasa track history in limiting the spread ofdisease. However, a number of con-cerns have arisen including:

• The emergence of human healthconcerns in the face of antimicrobi-al resistance.

• An increasing level and scope ofresistance to antiparasitic com-pounds.

• A public concern for the level ofresidues in food driven by an inc-reasing demand for efficiency offood production.

To satisfy these concerns the risinglevel of regulatory control has beenclaimed to stifle the development ofpharmaceuticals for minor species andfor minor diseases. In both cases thesecan have significant impact on regio-nal economies.

Vaccination provides a promise ofdisease control and prevention but inmany cases this is not yet achievableand does not eliminate the need forpharmaceutical treatments in the faceof disease outbreaks.

Areas for potential development inclu-de: • Novel routes of administration to

reduce the potential risk of residuesat injection sites.

• Safety and residue studies toexpand availability into the minoruse/minor species areas.

• Pharmacokinetic studies to reduceanimal experimentation and provi-de effective dosing schedules toreduce incidence of resistance andmaximise efficacy.

• Pain management.• Prophylaxis to effectively limit the

spread of disease.• Synergy between pharmacological

solutions to disease outbreaks andvaccination.

Traditionally pharmacological soluti-ons have been limited to bacterialinfection control and symptomaticmanagement of disease. The newtherapeutic solutions to viral infections

have limited application at present butwould offer advantages where in con-tact animals need protection duringemergency vaccination strategies.

The use of biocides to limit the envi-ronmental dissemination of disease isalso an important area of disease con-trol where biosecurity has importantimplications in the limiting the epide-miological spread of disease in animalgroups and between animal groups.

1.7 Conclusions

There is a demand for research intothe availability and effectiveness of thedifferent strategies for disease controlthat may include vaccination alone,vaccination and slaughter, a combina-tion approach between immunologi-cal solutions and pharmacologicalstrategies or eradication without vacci-nation.

New and improved vaccines arerequired for a range of major animaldiseases. In addition, improved dia-gnostic tests must be developed toenable the early diagnosis and detecti-on of outbreaks along with tests todemonstrate the effectiveness of con-trol programmes. The acquisition ofnew tools to control major diseasesand reduce dependency on prophy-lactic and therapeutic pharmaceuticalswill also have beneficial effects.However, the development of newpharmacological or biocidal solutionsto the containment and control ofdisease outbreaks may be more appro-priate in some circumstances andshould not be ignored.

1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8


2.1 Technological advances

Most of the vaccines currently in usefor the control of animal diseases haveconventional origins. Genomics offersnew opportunities through genesequencing and a range of other newtechniques. These have allowed theidentification of the genes in pathoge-nic agents that are responsible, forexample, for causing ill effects or sti-mulating an immune response. Thiswill enable the development of poten-tial vaccine strains in which the genescausing the disease have been disa-bled or removed while preserving theimmunogenicity inducing potency ofthe strain.

Identification of new vaccine candida-tes will speed up as a result of sequen-cing pathogen genomes. Geneticengineering can potentially lead to thedevelopment of new recombinantvarieties based on an altered gene,vector or sub-unit with the future pos-sibility of DNA vaccines and a rangeof other candidates. Marker vaccinesare also under development. Theseare essential for ensuring the differen-tiation of infected animals from vacci-nated ones when an eradication pro-gramme involving slaughter and/orvaccination is in place.

More effective delivery systems forthe vaccines and pharmaceuticals areurgently required to replace the pre-sent cumbersome and invasive techni-ques. Novel vaccines produced inplants or insect cells are under devel-opment, which could lead to newdelivery systems in the form of edible

and vector borne products.

In the case of pharmaceuticals an areafor exploration involves the potentialfor synergistic action between phar-macologically active substances andimmunostimulants. These may yielduseful prophylactic strategies and pro-grammes especially if combined withbiosecurity measures. Phage treat-ments may also offer an interim soluti-on to disease control but have not sofar been brought to a practical appli-cation.

There are a number of areas fordevelopment of diagnostic tests,which include the technology ofmicro-arrays, which could be grou-ped, by specific diagnostic areas suchas gastroenteric disease. This techno-logy could also be used to attain saferand more reliable purity control invaccines to detect cross contaminationduring production stages. Other tech-nologies include the development ofmultiple PCRs.

The move from R&D to successfuldeployment of new tools is complex,and involves many different playerswho need to interact and cooperate.The objective is to bring into actionhigh quality, safe and effective pro-ducts. The main challenges and con-straints to success can be consideredin three overlapping components ofthe R & D chain:• Research Position.• Industry Perspective. • Regulatory Aspects.

2.2 Research Position

At present Europe leads in a numberof key technologies, one of which isresearch into epidemic animal disea-ses. Research work to control infecti-ous diseases is a large part of EUresearch funding because of theimportance of animal health to agri-culture and the production of safefood. The quality of research remainshigh in Europe, but is at risk of expen-diture cuts in most Member States.

Research may be undertaken in publicor private laboratories. In either cir-cumstance the research phase compri-ses complex processes that are labour-intensive, require a multi-disciplinaryapproach and are of unpredictableduration. The success rate in produ-cing candidate antigens for a vaccine,for example can be low with less than10% of projects reaching a successfulconclusion. Costs are steep as a resultof the technologies involved and thecontainment facilities needed to pro-tect both human and animal health.

Currently, there are two main pro-blems concerning the facilities to per-form challenge trials using animalswhich need to be urgently addressed.There is a lack of suitable contain-ment facilities throughout the EU.This in turn can delay the develop-ment period for a vaccine with adirect impact on the competitivenessof the companies as the product islaunched much later than necessary.

There is also a lack of definition of theconditions of use of these specialised

1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8

2. The Development of Vaccines, Pharmaceuticalsand Diagnostic Tests


premises. The Regulatory authoritieshave not clearly defined whichmicroorganisms should be handledunder which type of containment.There is an urgent need to define cle-arly and precisely which microorga-nism should be used in contained faci-lities.

European research into epidemicdiseases is often spread over a relati-vely small number of public institutes.Research into zoonotic diseaseshowever, is more fragmented, beingspread over many institutes. Thisbecomes a serious problem in terms ofresources, particularly the availabilityof expertise, expensive equipment andfacilities needed to maximize utilizati-on of the new technologies.

No clear picture or overview is availa-ble of the totality of current researchinto the major diseases throughout theEU or indeed globally. There is noreadily accessible information onresearch funding by public authoritiesat a national or regional level, by largeanimal health companies or the smal-ler biotech firms. Information on plan-ned or proposed research is equallyunavailable. While animal healthcompanies may have extensiveresearch programmes, competitionand the protection of intellectual pro-perty rights often limit the exchange ofinformation.

Within the EU, the lack of a formalmechanism to identify research gapsincreases the reliance placed on scien-tific communities, panels and work-shops to assess these needs.Assessments are limited and need con-tinuous updating. Much of the currentpublic research funding is targeted atproblem resolution or at providing theevidence on which to base policies.Consequently, funding for innovationis less than is appropriate resulting indifficulties in filling gaps.

No single organisation or group has anoverview to ensure an integrated andcoordinated R & D programme acrossEurope. Provision of such as overviewwould reduce duplication of effort,lead to a more effective use of resour-ces and limited funds, encourage syn-ergies and enable major gaps inresearch to be identified and filled.

New and emerging infections willcontinue to pose a risk to human andanimal population. There is a need toanticipate and adopt a proactiveapproach for new virus discovery inorder to respond rapidly to new andemerging animal diseases, includingzoonoses. There is also concern overthe capacity for research in Europeand indeed worldwide, particularlythe availability of suitable premiseswith appropriate containment facili-ties, both for early stage research andlater stage clinical trials.

A similar concern exists for the availa-bility of veterinary medicines forminor species or for minor use inmajor animal species. In the USA aspecific programme has been succes-sfully funded and progressed to dealwith this problem. This may haveapplications to the European situationnot only for the minor species but alsothe development and delivery of vac-cines and tests for diseases whicheither do not occur in Europe or areof rare occurrence.

In the EU the critical mass of experti-se and the availability of qualified andskilled researchers are under threatcausing a potential impact on the long-term viability of some programmes.For many of the diseases, expertise islimited to a single individual. In someMember States, a worrying decline inthe number of veterinary graduatesentering research has been identifiedand this trend is likely to continue.

2.3 Industry Perspectives

Large multinational companies, espe-cially in the USA and the EU, domina-te the animal health industry. Thesecompanies have manufacturing facili-ties in different parts of the world, andthe profitability of the industry is influ-enced by the existence or otherwiseof national trade barriers.

More than 50,000 full time jobs inEurope depend on the animal healthindustry, with 15,000 directly invol-ved in R&D, production, marketing,sales and administration. The remain-der are indirectly involved as a conse-quence of the industry’s purchase ofgoods and services and the multipliereffect in other industries. TotalEuropean sales in 2003 were 3,700million euros, comprising 33.3% ofworldwide sales. The industry estima-tes that the lead-time to bring a newproduct to market is between 5 and10 years at a cost of up to 50 millioneuros.

The investment in R&D by theEuropean animal health industry isnearly 10% of turnover with an aver-age 12% of turnover for the multina-tional companies in Europe and 6%for the small- and medium-sizedenterprises (SMEs). However, in2002 the percentage of that R&Dbudget which was defensive andspent on keeping existing products onthe market is 35% in Europe compa-red to 16–18% in the USA.Nevertheless the recent new pharma-ceutical legislation in Europe adoptedin March 2004, must be implementedin the EU Member States in the lasttrimester of 2005 (Regulation726/2004; Directive 2004/28/ECamending Directive 2001/82/EC).

The new legal framework includesimprovements in terms of timing ofauthorisation procedures, removal ofrenewals (thereby reducing the costs

1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8


of defensive research significantly),broadening the scope of the so-calledcentral authorisation of specific veteri-nary vaccines (thereby opening theeligibility in the whole Community forveterinary vaccines against majorCommunity related animal diseases –Article 3.2 of Regulation 726/2004).

The above statistics are from the 2002survey. It would be appropriate toconduct an up to date survey to takeaccount of the new EU legislation andto assess the comparative positionbetween the USA and Europe in2005.

For new conventional vaccines, thedevelopment phase is labour-andcost-intensive with an average successrate of 30%. For live recombinant vac-cines to be successful an environmen-tal impact assessments (EIA’s) will berequired and this is difficult to quanti-fy. The cost and time needed toresearch and develop new productshas increased and is foreseen to conti-nue to increase for a number of rea-sons. Costs are higher for biotechno-logy-derived vaccines than for con-ventional vaccines. This is compoun-ded as the market for veterinary vacci-nes is relatively small and is also very

fragmented with a multiplicity of targetspecies and diseases. Consequentlythe costs for R&D and authorisationdo not balance with the expected pro-fitability.

In the centralised authorisation proce-dure (Regulation 726/2004), the feesfor the authorisation of vaccines arecurrently half the costs for that ofpharmaceuticals. In particular theoverall fees of central authorisation ofveterinary medicines are considerablylower than for human medicines.

A report presented to FEDESA, nowIFAH (International Federation forAnimal Health), in January 2002benchmarked the competitiveness ofthe European animal health industry.The findings in the report were basedon two quantitative surveys and aseries of qualitative interviews withcompanies in Europe and the USA.The companies identified innovationas the major driver for long-term com-petitive success. However, this suc-cess depended on a number of criticalfactors that affect on the process ofinnovation, including the marketingauthorisation procedure, the small sizeof the market segments and the closu-re of European markets to certain pro-

ducts. Similar problems were identi-fied in the USA.

In the past companies considered thatthe regulatory framework created pro-blems for innovation by increasingdevelopment time and costs, creatingsignificant uncertainty and redirectingresources into defensive R&D. Whilethere were similar regulations in theUSA, its companies are not subjectedto the same constraints and detailedregulations as their European coun-terparts. There was a measurable andsignificant negative impact on costs,time and risks of developing new pro-ducts and maintaining existing ones.

As already indicated the survey andreport are out of date (2002). The EUpharmaceutical legislative frameworkthat will prevail until 2015 is thenewly adopted one which must beimplemented by the end of 2005. Itwill be important to assess whetherthe new regulatory framework resultsin improvements by comparison to theresults of the 2002 benchmarking sur-vey. It would be unwise to judge theimpact in advance of the implementa-tion.

The technical annex, (Annex 1 ofDirective 2001/82/EC as amended byDirective 2004/28/EC), fixing thequality, safety and efficacy data requi-rements to be submitted in an applica-tion for a marketing authorisation forveterinary medicines is currentlyundertaken is under revision. This willtake account of the achievementsobtained through the InternationalCooperation on Harmonisation ofTechnical Requirements forRegistration of Veterinary MedicinalProducts (VICH) and further develop-ments in the sector of veterinary medi-cinal products. This revision will leadto simplification of the general requi-rements that are needed in so far as touse resources for the development ofnew veterinary medicinal products in

1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8


an economic way and to promoteenhanced activity in this area.Additional guidance on requirementsfor the specific marketing authorisati-ons applications, such as generics, aut-horisation in exceptional circumstan-ces, will be provided in line with thecorresponding Annex 1 to Directive2001/83/EC relating to medicinal pro-ducts for human use.

2.4 Regulatory Aspects:Vaccines

The potential of new advances invaccine development cannot be fullyexploited if there is no public accep-tance of the technologies involved.Safety and ethical concerns have to betaken seriously and attempts need tobe made to inform and educate thepublic on the benefits and risks of newtechnologies. Regulations on themanufacture, production, authorisati-on, distribution and use of vaccinesare critical to protect human and ani-mal health, animal welfare and theenvironment. They are also importantin establishing and maintaining consu-mer confidence in the safety, quality,and efficacy of products.

The regulatory requirements are verymuch predicated on societal values ofthe day. These are reflected in therequirements of the legislators in parti-cular to ensure that all aspects of safe-ty are addressed both in the authorisa-tion of veterinary and human medici-nes.

Considerable investments have to bemade to meet regulatory require-ments. The manufacturing phaserequires quality assurance systems thatare important for the quality of theproduct and the safety of the environ-ment and the workers. To meet thedemand for predictable safe and con-stantly effective vaccines, new techni-ques need to be used which will inc-

rease testing and development costs.The production phase is governed byGood Manufacturing Practice, otherlegislation and monographs of theEuropean Pharmacopoeia that coverall stages from the starting material tothe finished product.

Scientific assessments of applicationsfor marketing authorisations of veteri-nary medicinal products in the EU isoperated either centrally by theEuropean Medicines Agency(EMEA)/ Committee for VeterinaryMedicinal Products (CVMP) or natio-nally (National Regulatory bodies)and includes the strict evaluation ofthe safety, quality and efficacy of theproducts. A given veterinary medicinecould be authorised in all 25 EUMember States (Community authori-sation), or in 2 to 25 Member States(Mutual recognition) or only in oneMember State (Strictly national autho-risation).

As a consequence a vaccine authori-sed by one Member State will notnecessarily be authorised for use bythe other 24. This is true in the case ofmany vaccines against epidemic disea-se such as FMD, Avian Influenza, andBluetongue. CSF vaccines are theonly ones that have had a Communityauthorisation and consequently areauthorised in all 25 EU MemberStates.

The procedures for approval and aut-horisation of vaccines are becomingmore complicated and costly with theneed for pre trial approval beforegenetically manipulated candidatescan be considered for release from thelaboratory. The national arrange-ments in relation to the authorisationof studies for testing GMOs as oppo-sed to the licensing system for veteri-nary medicines are fraught with diffi-culties as there are usually differentauthorities, committees and groupsinvolved in each Member State.

These differences make the processfrom development to delivery unclearleading to difficulties in developingnew vaccines and performingEurope-wide trials.

In order to exploit the results ofresearch and to deliver new products,a number of important stages in theR&D chain need to be successfullycompleted. These involve an integra-ted approach to product develop-ment, production, good manufactu-ring practice, initial clinical trials andfinally the large-scale field trials inorder to reduce the time-to-marketand cost of a product. To achieve this,a cooperative interaction is essentialamong the different parties involved inthe process from discovery to delive-ry. This suggests early regulatoryagency involvement, enabling theregulatory requirements to evolve inparallel with technology advances.For Community authorisation applica-tions, scientific advice may be provi-ded by the CVMP in the early stagesof product development and conse-quently benefits the whole processingof such application and the delivery ofveterinary medicines.

A good regulatory framework is bene-ficial for the animal health companiesby preventing dangerous productsentering the market, improving pro-duct quality and reassuring the public.Good regulation also provides apowerful stimulus to innovation byprotecting the investments in intellec-tual property, facilitation of productentry into global markets and providesconsumer confidence in the products.Conversely, poor regulation will redu-ce the number of products, divertR&D, increase costs, time and risks ofdevelopment and ultimately lead tofewer products and the possiblemigration of the industry out ofEurope.

At present there is a need to examine

1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8


the regulatory framework and to seekthe consensus of all stakeholders as tothe right balance between protectionand avoidance of risk and the need fordisease control products. While con-sumers expect new technologies to befully utilised in controlling diseases,the time for the development of theseproducts is increasing, leaving theindustry reluctant to invest in them.

2.5 Regulatory Aspects:Diagnostic Tests

There is as yet no formal mechanismfor the approval or authorisation ofdiagnostic tests, although internationalguidelines for the validation and stan-dardisation of diagnostic tests do exist.The OIE established a “procedure forrecognition” of diagnostic tests, inclu-ding commercial kits, through itsworldwide network of over 150 refe-rence laboratories in 31 developedand developing countries. This is ofparticular importance with the selecti-ve tests to differentiate vaccinatedfrom infected animals and whereinternational endorsement is essentialif importing countries are to accept thetests. These tests ultimately determinethe status of a country.

Four development requirements havebeen identified:• Validation. • Standard protocols. • International reference sera or

materials. • Proficiency test.

One of the problems in authorisingtests in the EU is the availability ofvaccinated animals to be challengedwith the pathogen but which, becau-se of the seriousness of the disease,cannot be challenged outside veryhigh-category containment facilities.Consequently most of the testingwould have to be carried out in thedeveloping countries where the disea-se is endemic.

2.6 Regulatory Aspects –Pharmaceuticals

The key regulatory issues that haveaffected the development of pharma-ceuticals are consumer safety particu-larly in respect of residues, and resi-stance. Environmental safety is ano-ther important consideration. With areview of residues legislation plannedby the EU, a process that assures thesafety of consumers without the needfor expensive and repetitive residuedepletion studies is desirable. For resi-stance, the science is being developedin several areas but the assessment ofoptimum dose and acceptance by theregulatory authorities of new methodsis slow to evolve.

A more rapid acceptance of newadvances in pharmaceutical scienceand the development of an improvedapplication of Risk Benefit analysiswould be helpful in encouraging thedevelopment of new and innovativetreatments.

2.7 Conclusions

All of this underlines the need for acoordinated, transparent and multidis-ciplinary R&D effort from basic sci-ences through to the emerging techno-logies and onto product development,production, authorisation and distribu-tion. There are a number of con-straints on the successful transfer frombreakthrough to the deployment ofnew and improved veterinary medici-nes be they vaccines or pharmaceutic-als, and diagnostic tests for the majoranimal diseases:

• Research: lack of investment, frag-mentation, duplication, lack of co-ordination, no overview, nomechanism to identify gaps, lack ofEU and world wide expertise andfacilities, high costs of cutting edgescience, costs of containment facili-ties.

• Production and Manufacture: highrisk, uncertain profitability, lowfinancial returns, increasing costs,low demand from developedcountries, and inability of the deve-loping countries to pay.

• Regulatory: extensive tests, withhigh costs for authorisations, poten-tial problems with GMOs prior tothe medicine authorisations, poorimplementation of mutual recogni-tion principles during the authorisa-tion process, lack of coordinationbetween Member States’ interpre-tation of the harmonised technicalrequirements – mainly in safety andefficacy, while worldwide authori-sation and quality control needs tobe developed further.

1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8


1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8

3.1 A European TechnologyPlatform

To meet the many and varied challen-ges discussed in this paper, aEuropean Technology Platform forGlobal Animal Health was launchedon 16 December 2004. This will pro-vide a mechanism for focusing andprioritising the research that ultimatelydelivers new or improved tools suchas veterinary vaccines and diagnostictests. It will also help to speed up thedelivery of new products to the mar-ket by overcoming the constraintsidentified throughout the supplychain.

The Technology Platform will beinstrumental in developing a compre-hensive approach through the prepa-ration of a visionary StrategicResearch Agenda. The elaboration ofthis and the associated implementationplan is the central element of the pro-cess. It would be ambitious, medium-to long-term in span, explicit in settingout priorities and updated regularly.

3.2 European Objectives

There are a number of challengesimplicit in the global disease situationand the risks facing Europe. OverallEuropean objectives must be to:

• Protect Europe from the incursionof epidemic animal diseases andzoonoses.

• Deal rapidly and effectively withoutbreaks in Europe should theyoccur.

• Assist in speed of access to market,facilitation of world trade and thealleviation of poverty by reducingthe impact of these diseases indeveloping countries.

• Reduce worldwide levels of disea-se and thereby indirectly protectEurope from disease spread bypeople or trade.

3.3 Meeting the Challenges

There is a pressing need to facilitateand accelerate the development anddeployment of these new tools to ena-ble effective control of animal diseaseand to meet the above objectives. Inthe first instance, the delivery of newtools such as vaccines and diagnostictests for a range of epidemic animaldiseases and zoonoses is essential.Linked to this is the need to ensurepublic support for these aims and toensure society's demands for safe andeffective medicines are met.

Europe cannot afford to miss out onthe benefits offered by the new toolsfor animal disease control that theadvances in biotechnology and geno-mics will generate. It is important tocapitalise on the potential of the newtools but at the same time recognisingsociety demands that safeguards bebuilt into the regulatory system. This isespecially so with GMOs where thereare important public concerns as tothe risks associated with these pro-

ducts.

A number of important challengesneed to be overcome. The producti-on of new tools such as vaccines anddiagnostic tests, involves a supplychain beginning with research andpassing through development tomanufacture, production, authorisati-on, sale and finally distribution. TheEuropean Regulatory Framework(Veterinary Medicines andCommunity Animal Health l legislati-on) establishes conditions for the aut-horisation of veterinary medicines, forvaccination policy ("vaccinate to livepolicy") providing or not the incentivesto companies to develop product andinevitably impacting on the finaldelivery of veterinary medicines.

This is an extensive agenda and inorder to meet these challenges Europemust take steps forward in relation toits: • Research Policy.• Global Dimension.• Interdisciplinary Research.• Intellectual Property Rights.• Industry Issues.• Regulatory Framework.

3.4 Research Policy

Europe has a long tradition ofresearch into major animal diseasesand in the development of vaccinesand tests. With high-calibre academicand government research institutes,Europe is well placed to continuewith innovative research in theseareas. However there is a need for:

3. Developing a Vision for 2015:From Innovation to Delivery


1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8

• Enhanced identification of oppor-tunities in close cooperation withthe industry.

• Coordination and enhanced publicprivate research partnerships tomove beyond the normal arrange-ments and to ensure that discove-ries are fully utilised.

• Collaboration to avoid duplicationbetween public sector and privateindustry research.

The 6th EU Framework Programmeseeks to reduce fragmentation, deve-lop synergies, avoid duplication, andenhance integration and coordinationof the programmes of research. Withmajor animal diseases it is important tostrengthen competencies and networ-king aimed at increasing collaborationbetween research centres, referencelaboratories and other stakeholders.This is an essential component instrengthening the research area and inensuring that Europe’s position is notundermined.

To meet some of these concerns theEU has established networks of excel-lence. One of these is the MED-VET-

NET, which has a remit to preventand control zoonoses. A group, whichconsiders the research activity, mana-ges each network. There are regularworkshops to communicate the resultsback to industry. There is consultationwith the public through open forawhen their views and opinions can beincorporated into the research directi-on. Another network of excellence isEPIZONE, which aims to improveresearch on preparedness, preventi-on, detection and control of epizooticdiseases. The ERA-NET schemeaims to support cooperation and coor-dination of national or regionalresearch programmes.

However, none of these networks hasthe full participation or integration ofthe animal health or biotechnologyindustries to assist in coordination andcollaboration and avoid duplication ofeffort. In order to avoid repetition, amuch wider mechanism is needed toevaluate all the research from innova-tion to application in a specific area ofwork. One way of achieving this is todevelop a Strategic Research Agendato which all those involved in the

chain contribute.

Most large animal health companiesdo not engage in the research thems-elves but let universities and small bio-tech start-ups identify some potentialproduct from which they buy theintellectual property and then developit further. Given the nature of thisresearch, it is important to work close-ly with the commercial companies tomove innovations to actual products,but at the same time to also have arange of companies or groups toundertake fundamental strategicresearch to identify better vaccinesand tests.

3.5 Global Dimension

The benefits of reducing global risksand thereby the threat of introducingdiseases into Europe and improvingglobal equity are considerable. Inaddition there will be increasing live-stock business opportunities in develo-ping countries. Demand for livestockand livestock products is growing atmore than 5% per annum in the deve-loping world, much faster than inEurope. This increasing demand willoffer new markets for livestock inputsincluding vaccines, pharmaceuticalsand diagnostics.

The focus of the Strategic ResearchAgenda should not be aimed exclusi-vely at a European level, but shouldalso consider the global dimension ofthe technologies concerned.Improved links to R&D worldwideshould be a priority. The scale andcomplexity of vaccine and diagnosticsdevelopment is such that allianceswith other countries and internationalorganisations such as the OIE andFAO will be essential. Participation by


1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8

developing countries e.g. throughreference laboratories of the OIE andFAO, would be highly beneficialespecially in the field trials of somediagnostics and vaccines for exoticdiseases such as FMD which is absentfrom the EU but endemic in othercountries.

Research carried out in the countriesof origin of these diseases will providelessons on the epidemiology of theproblem. It also allows for the testingof control approaches including vacci-nes and diagnostics. Many epizooticpathogens cannot legally be introdu-ced into Europe for research purpo-ses. More importantly, research suchas field trials of diagnostic tests can beconducted in the developing world,which, for both technical and practi-cal reasons, cannot be carried out inEurope. Ethical issues must be takenin to account in these circumstanceswhen research is proposed in develo-ping countries which would not bepermitted in Europe.

Full engagement of developing coun-try partners will be critical to conductresearch in an effective manner and tohaving researchers within these coun-tries that understand the issues andsupport the implementation of subse-quent control programmes. Thus acti-ve engagement of the developingcountries and modern research part-nerships are essential for the Platformto be effective. This implies the needfor strategic joint programmes invol-ving research and capacity building. Apostgraduate programme for develo-ping country nationals and EU natio-nals might be a cornerstone of the ini-tiative, creating a powerful internatio-nal network to handle global pro-blems.

3.6 InterdisciplinaryResearch

There is a strong requirement toencourage interdisciplinary researchwith more collaboration betweengroups working on human and animaldisease and zoonoses. Therefore, thisshould be explicitly built into thedesign of the Platform to make surethe lessons are shared. Animalresearch has potential to produceimportant lessons for human vaccinedevelopment and thus to speed up theprocess for the control of key humandiseases such as malaria, tuberculosisand HIV/AIDS and vice versa.

Close links must be developed withthe other technology platforms especi-ally those for innovative medicines,sustainable chemistry, and nano-tech-nology – all of which can contribute tothis Technology Platform.

3.7 Intellectual PropertyRights (IP)

An innovative systems approach invol-ving diverse stakeholders is veryimportant. Industry should clearly playan important role, but it will be neces-sary to have the representatives think‘outside the box’. Ideas about handlingIP are going to be crucial if progress isto be made. There is increasing recog-nition that too heavy an emphasis onIP protection is hindering the progressof science in addressing big societalissues. Public-private partnerships willbe key to such progress. Analysts frombeyond the animal health industry willhave to be brought on board to thinkthrough the science policy issuesinvolved.

3.8 Industry: Manufactureand Production

Despite the scientific advances andtechnology already available to theanimal health industry, progression invaccines and diagnostic tests has beenlimited. One of the reasons for this isthat companies consider both thepotential demand and acceptable saleprice for vaccines or tests to be toolow for them to recoup their invest-ments. It is important to provide incen-tives for vaccine research and to ensu-re that if vaccines and tests are deve-loped, they are genuinely answeringthe users’ demands, reach the correcttargets and comply with internationalstandards on quality, safety and effica-cy. There are strong arguments forglobal partnerships to spur vaccinedevelopment and ensure that theappropriate vaccines are available tothose who need them.

Vaccines for epizootic diseases maynot always be profitable for the priva-te sector depending on demand forthem and the volumes manufactured.The market potential for diagnostictests is even smaller and there are fewincentives for the industry to invest inR&D. This leads to a broader area ofpolicy research: how to assess the riskof these outbreaks of major animaldiseases and how to pay for a strategywhich will benefit whole societies, aswas seen by the costs of FMD in therecent UK outbreak. Thus, thePlatform should also include a compo-nent on the economics of handlingthese risks. Such research would haveto go beyond the traditional cost-benefit analysis and include socialcosts and consumer attitudes, inclu-ding the animal welfare perspectivesand the interest to involve public


1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8

resources in a field considered as anInternational Public Good.

This should provide the arguments forpublic investment in research and forfinding mechanisms to pay for the pri-vate sector involvement in the produc-tion and maintenance of vaccinebanks to respond quickly to outbreaks.These mechanisms could be handledat a national or regional level.Companies cannot be expected todeal with these issues in the usual wayi.e. by selling each vaccine in doses.They should instead be involved inservice contracts to provide risk miti-gation at a certain price. This involvesthinking quite differently about privateand public roles in dealing with out-break risk.

In a world of decreasing support forpublicly funded development initiati-ves, strong coalitions are needed tobuild the confidence of the financialsector. These coalitions should workwherever possible to attract fundsthrough sound proposals based oncooperation between key players tooptimise the productivity of availableresources. This requires consensusbuilding between stakeholders.

Regarding the international collabora-tions that the EU Animal Healthindustry may have with institutions inthe developing world, the most obvi-ous category is technology transfer. Itis feasible that the private sector insome developing countries couldmanufacture products under licence.A more important aspect in vaccinedevelopment will be in joint ventureswith both the public and private sec-tors in developing countries.Developing country partners can bringlocal knowledge of the disease situati-on, the business context and the regu-

latory environment. The key inputs ofthe European partners would be inthe research and development pro-cess. Partnership agreements and theresolution intellectual property rightswill be important factors for success.

3.9 Regulatory Aspects

The impact of emerging technologieson discovery and development ofnew vaccines and diagnostic tests isclear. However tests of the resultinggenetically based products poseimmense challenges. Efficient newtests, methods and tools need to bedeveloped to meet the safety, qualityand efficacy standards. As a conse-quence, a shift in regulatory require-ments for the authorisation of newvaccines and development of harmo-nised requirements for the approval ofdiagnostic tests may be required. Acontinuous dialogue between regula-tors, academics and the animal healthindustry is required in order to keeppace with the technological develop-ment and its application to diseasecontrol.

Unfortunately regulation can have anegative impact on innovation andthose responsible for the developmentof products – particularly vaccines forepizootic animal diseases where thedata and information required to justi-fy an authorisation can be expensiveand difficult to obtain. The regulatoryrules in Europe and in each MemberState are complex but with the newEuropean legislation the authorisationprocesses for veterinary medicines areevolving. However further streamli-ning and improvements are needed inthe processing of applications for thetesting of GMOs.

It is apparent from the present situati-

on – which is mirrored in the medicalfield – that a number of issues need tobe resolved in relation to the develop-ment of new tools for major animaldiseases such as vaccines: • The need for better implementati-

on of the harmonised regulatoryrequirements among EU MemberStates for vaccines used to controlepizootic diseases.

• Clear fast track facilities forEurope-wide marketing authorisati-ons to be obtained for such vacci-nes.

• Improved communication of infor-mation providing an overview ofthe regulatory requirements to beavailable to academia and theSMEs.

• Improved involvement of the regu-latory authorities as an integral partof the process from innovation todelivery.

• The need for epizootic animaldisease vaccines to have marketingauthorisations covering the 25Member States.

• The need for diagnostic tests to bevalidated and independentlyapproved in compliance with inter-national standards to give confiden-ce to countries and their tradersusing the tests.

• The need for better use of pharma-ceuticals to limit and combat disea-se, especially in the face of resistan-ce.

3.10 Conclusion

To meet these challenges Europe mustdevelop and implement innovativesolutions working in partnershipsthrough the Technology Platform,which should have specific well-defi-ned activities and outcomes.


1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8

4.1 Partnerships

The Platform brings together all therelevant stakeholders at EU and natio-nal levels. It will consist of networksinvolving a range of partners basedaround industry and including acade-mia, animal production stakeholders,policy makers, consumers and otherkey partners including internationalorganisations such as OIE and FAO,International Research Institutes suchas ILRI and other countries. The dri-ving force for the platform will be allthe stakeholders working together.

A high degree of industry-academiacollaboration is important, as it willimprove access to expertise and resultin shorter lead times to market for pro-ducts. Collaboration is particularlyimportant for the small biotech com-panies but even the larger companiesbenefit through access to academiaand publicly funded research institu-tes. The platform should also create acompetitive environment where manysmall players, both private and public,can obtain funding in smaller amountsto explore ideas.

This should be accompanied bybroad funding for basic science withpotential to provide new generic toolsfor vaccine and diagnostics develop-ment (pre-competitive research) on anagenda developed by not only the bestminds of academia and commercialcompanies but also all the stakehol-ders including producers and consu-mers. This research would also sup-port the development of effectiveregulatory approval processes.

4.2 Main activities

The key activities of the TechnologyPlatform will be to: • Prepare with all stakeholders a

Strategic Research Agenda andassociated implementation plan notonly to identify the new and inno-vative solutions for veterinary vac-cines development and diagnostictests but, also to cover broaderissues relating to global animalhealth and improved methods tocontrol animal disease.

• Provide a European dimension tothe plan, with the promotion of acoherent policy to develop co-ordi-nation of research and stimulatecross- disciplinary collaborationthroughout Europe.

• Ensure a research environmentthat stimulates innovation, backedup with a critical mass of researchcapability including a satisfactoryinfrastructure, adequate funding,capacity to react rapidly to newand emerging problems and produ-ce the tools for existing animaldisease problems including zoon-oses.

• Identify mechanisms to mobilizepublic and private financial supportfor R & D from Member State pri-vate companies and investors.

• Enhance the transparency of R&Din Europe, the Member States, theregions, and locally.

• Mobilise and involve all stakehol-ders to develop more effectiveinformation networks, consensuson methods priorities and values,avoid duplication and ensure a cri-tical mass of research through thecollaboration of public – privatepartnerships.

• Maintain a competitive edge withindustry working in partnershipwith academia, the public sectorand regulators to develop andimprove the ability to convert inno-vation into the delivery of practicaltools for the control of animaldisease.

• Ensure a supportive and harmoni-sed regulatory framework thatbalances risk against need, workingin agreement with all concerned asto the acceptable levels of risk.Identify constraints with respect toregulation which impact on thedelivery and use of authorised pro-ducts at the front line.

• Improve education, skills and trai-ning for those involved in the stagesfrom innovation to application

• Establish an ongoing communicati-on and dialogue process with thepublic to build confidence in thenew technologies and raise aware-ness. Address public concerns toincrease consumer confidence inthe quality and safety of livestockproducts.

4. The Way Forward: Developing a TechnologyPlatform


1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8

4.3 Platform Organisation

The Technology Platform will beindustry led and enable all stakehol-ders including farmers to interact andcontribute to the development of thelong-term future. The involvement ofall the key stakeholders as partners willbe essential for the development of ashared vision and Strategic ResearchAgenda.

The Industry led Technology platformwill provide:• A process to manage the input and

expectations of multiple stakehol-ders and promote understandingand consensus between diversegroups.

• A forum for all stakeholders towork together to create a commonvision for the future of disease con-trol and to address the constraintsto the delivery of that vision.

• A mechanism for the developmentof a Europe-wide agreed StrategicResearch Agenda for GlobalAnimal Health with an implemen-tation plan detailing priorities andmilestones to ensure the vision willbe achieved.

• A financial plan to mobilise public-private resources for collaborativeR&D to meet the research and

development priorities.

The proposed Technology Platformwill have 5 components: • A Steering Council. • An Executive Board.• A Stakeholder Forum. • Member State “mirror groups”. • A Secretariat.

The Steering Council is at the core ofthe ETPGAH. It is a network connec-ting the platform to the major stakehol-der and the pool of ideas. It will over-see the technology platform and act tomove the platform forward. The pre-cise role of the Steering Council willbe published separately.

It is possible that not all stakeholderswill be on the Steering Council.Membership of the Council should bea balanced and where appropriatethere may be single representationfrom each of the main stakeholdergroups. There should be around 25members, with a quorum of twothirds. Membership of the SteeringCouncil should include the key stake-holder organisations at a Europeanlevel. Developing countries would berepresented on the Steering Councilby the OIE and the FAO, theirresearch bodies and institutes wouldbe represented by ILRI.

An Executive Board will be responsi-ble for developing and administeringthe technology platform. The detailedrole of the Executive Board will bepublished separately. It will comprise7 members drawn from the SteeringCouncil. This would include 1 mem-ber each from industry, users (vetsand farmers), academia, researchinstitutes, regulatory authorities andinternational organisations. In additi-on the Executive Board will be chai-red by IFAH-Europe.

A Stakeholder Forum is essential asthe active and committed involvementof all the stakeholders is vital to thesuccess and credibility of anyTechnology Platform. The forum willbe a multi-disciplinary consortiumincluding industry, public and privateresearch institutions, universities,public authorities, livestock, produ-cers, civil society, consumers, fundingbodies, third countries, internationalorganizations (e.g. OIE, FAO,) andInternational Research Institutes (e.g.ILRI). There would be approximate-ly 75 stakeholder members of theforum representing the major organi-sations with an interest in the plat-form.

For those who are not invited to parti-cipate at meetings of the stakeholderforum it will be essential to ensuregood communication channels. A listof all potential stakeholders should beestablished and would include repre-sentatives from NGOs. The widerstakeholder base would be involvedvia email and the website. All docu-ments should be available on the web-site for information and comment.Member States: To be successful andallow coordination the TechnologyPlatform will need the participationand commitment of the MemberStates. The interface between theTechnology Platform and Member


1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8

States can be organised in a numberof ways. These need to be exploredto identify the most effective mecha-nisms (e.g. the use of mirror groups).

The Secretariat to support the plat-form is essential. This could be provi-ded by industry and academia sharingthe costs or by identifying a specificsource of funding. The secretariat willdeal with the administrative matters oforganising and running the day-to-dayarrangements for the platform.

Working Groups will be set up to ela-borate the recommendations for theStrategic Research Agenda. The sta-keholders will nominate their expertsto these groups.

4.4 Outline for the StrategicResearch Agenda

The Strategic Research Agenda willcover a period of 10–15 years whichwill allow long-term priority require-ments to be identified as well as thepotential funding from the public andprivate sector. The Strategic ResearchAgenda also needs to address the keyissues of European competitivenessalthough the immediate purpose is todevelop vaccines to prevent and con-trol disease by using new technologiesand making the most effective use oftechnologies currently available.

The detailed Strategic ResearchAgenda will need to be formulated byall stakeholders and will need to con-sider a range of requirements to meetthe aims of the platform. A prelimina-ry discussion among the High LevelGroup identified three potential areasfor R&D. The initial suggestions were: • Focus on R&D, which could provi-

de a more evidence-based regula-tory framework by developing bet-

ter diagnostic test methodologies.These would enable the effectiveassessment of the safety, qualityand efficacy of new or modifiedcandidate vaccines, diagnostic testsand medicines.

• Develop innovative technology lea-ding to more effective vaccines

• Research into the basic immunolo-gical responses in all target animalspecies for different diseases.

Other suggestions included the vecto-risation of antigens and focusing onvaccines inducing early immunity. Itshould also be recognised that vacci-nes are not the only tools and thedevelopment of pharmaceuticalsincluding antibiotics and anti-viralsshould not be ruled out.

The initial discussions on the SpecificResearch Agenda (SRA) at the stake-holder forum on 24 February identi-fied three main themes: Research,Technology Transfer, Horizontalissues. Cross cutting issues, whichwould need to build into a matrix withthe three themes included, sustainabi-lity, competitiveness, security from bioterrorism, public health including foodsafety, food security and marketaccess.

Other area for consideration includebreeding for disease resistance and thepotential use of advanced technolo-gies for control of disease.

It was agreed that three workinggroups would be established to deve-lop the research agenda for the threethemes. Terms of Reference, manda-tes, membership and identification ofthe chair will be developed. Workinggroups will consist of about 25 peopleand would meet twice during thedevelopment of the SRA.

Nominations to Working Groups tobe done by each organisation beforeend of March.

Throughout the SRA elements suchas food quality, public health, foodsecurity, competitiveness, marketaccess, sustainability and environmentmust be taken into account.

4.5 Roadmap and Milestones

The launch of the TechnologyPlatform is the start of the activities. Atthis early stage the goal of the techno-logy platform should be to bring toge-ther representatives of all interestedstakeholders to cooperate to:• Refine and finalise the vision. • Determine the research require-

ments. • Define a dynamic research agenda

including the design and frame-work of EU and external alliances.

• Identify strategic priorities. • Prepare and agree the Strategic

Research Agenda. • Develop an implementation plan

with milestones.

Implementation plans will be develo-ped to ensure the Strategic ResearchAgenda delivers the vision. Road mapswill be produced with milestones thatwill need careful monitoring. Theroad map derived from the StrategicResearch Agenda will be for all partiesinvolved and for the private andpublic sectors to realise together. Amechanism will be needed alongsidethe support of the Steering Council tomonitor progress and take action toterminate programmes if it becomesapparent that they will not deliver.


1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8


Printed by De SmetBelgium

For further information on the European Technology Platform for Global Animal Health, please contact:

Mr. Declan O’Brien,Managing Director – IFAH-EuropeTel +32 2 543 7569 – E-mail: [email protected]

Dr Isabel Minguez-Tudela – Research DG Tel +32 2 299 21 09 – E-mail: [email protected]

Dr Philippe Steinmetz – Development DG Tel + 32 2 295 30 57 – Email: [email protected]

Useful Web addresses http://www.ifah.be/Europe/EUplatform/platform.html http://www.europa.eu.int/comm/research/biosociety/index_en.htm http://www.cordis.lu/technology-platforms

HHHH HHHH HH

HH HH

HH HHHH HH

HH

Kaft 07-12-2005 11:47 Pagina 4

European Technology Platform for Global Animal Health · PDF fileEuropean Technology Platform...

Documents

Transcript of European Technology Platform for Global Animal Health · PDF fileEuropean Technology Platform...