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GLOBAL ROADM AP FOR IM PROVED CONT ROL OF FM D IN ENDEMIC SETT INGS

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Global Roadm ap Works hop on Improved Control of FM D in Endem ic Se ttings Fr om the Dr aft Re port of the w orkshop held in Agra, Ind ia 29th No vember to 1st December 2006,

Sponsored b y t he W ellcome Trust and EC ( DG- Research).

Vision : A world in which livestock -b ased livelihoods, enterprises and trade can flourish unim peded b y foot-and-mouth disease

Mission : To estab lish and sustain global partnerships involving institutions in footand-m outh endem ic and free areas to develop, test and promote pack ages of tools needed for the successful control and eventual elimination of the disease in endemic settings

Ex trac t f rom the “”Way Forw ard””

• The m andate of the Global Roadm ap for Im proved Control of FMD in Endem ic

Settings is the development, tes ting and m aking available of packages of tools for F MD control. The m andate is not the control of FMD its elf, the responsibility for which lies with countries , regions , regional organis ations (s uch as the SE As ia FMD Programm e, and PANAFTOS A, for e xam ple) and international organis ations (s uch as FAO and OIE). • An ins titutional m echanism to catalyse and facilitate effective partnership and communication between the many international contributors to the Roadm ap m andate would greatly increase the chances of its success . • Such a mechanism s hould have both an “action” element (the facilitation, and in som e areas coordination, as pects ), such as a sm all functional Strategic

Steering Group as recomm ended by the People and Process team at the works hop, and an “overs ight” group (s uch as an Advis ory Board) that ens ures repres entation of key s takeholders in FMD-endem ic settings , as well as researchers and international bodies . • The three currently active m echanisms considered to be highly relevant to the

Roadmap are: o The Global FMD Research Alliance (GFRA). This is primarily a research partners hip of the high security F MD laboratories in the USA, Canada, UK and Aus tralia, but also includes ILRI which has cham pioned the endem ic FMD roadmap process as part of the GFR A’s Programm e 2.

o The FAO European Commission for the Co ntrol of FM D ( EUFM D), based at FAO headquarters in Rome. o The Coordinated Res earch Programm e (CRP) m echanism of the

FAO/I AE A Joint Divis ion, bas ed in Vienna. o It w as concluded that t ogether all had a l ot to offer to t he roadmap, but i n their current form and w ith their current mandates all w oul d be required to implement changes in order to serve the mandate of the Roadmap.

Timetable Action Date to be complete d Draf t elec tronic v ers ion of A gra w orks hop report dis tributed 20 Dec Rec ruit le ad w riters 12 Jan

l atest Lead w riters prov ide “tidied-up” tabl es of “w hat” and “how ” 31 January Lead w riters c omplet e draf t c onc ept notes 19 Feb Draf t c onc ept notes pos ted on w eb 19 Feb – 9

M arch

Lead w riters f inalis e c onc ept notes Road map report f inalis ed and pr inted Launc h me eting f or report

23 M arch 13 April 2nd hal f April

Launc h: organis er propos e a one-day meet ing, probably to be he ld in Brus s els in A pril, to w hic h potential donors and other key partners (IFA H, FA O, IA EA ) w ill be inv ited. A pres s releas e w ill be prepared and a c o mmu nic ation s trategy w ill be dev eloped to f ac ilit ate generation of publ ic ity and appropriate nat iona l and internatio nal me dia c ov erage.

Global Roadmap W orkshop on Impro ved Contro l of FM D i n En demic Settings Extracts from the Draft report of a w orkshop hel d in Agra, I ndia 29th November to 1st December 2006

Roadmap’s mandate Af ter s om e dis cuss ion, the works hop participants decided by a large m ajority that the s elf-appointed mandate of the Roadmap s hould be limited to ‘developing, tes ting and m aking available packages of tools for the control of FMD in endem ic s ettings’. It was agreed that the use of those tools , for exam ple in FMD control cam paigns , fell beyond the mandate of the Roadmap: the group assem bled in Agra were m os tly highly experienced ‘tool makers ’, with the tools including vaccines , diagnos tics and epidem iological and econom ic tools . It was recognised that the m andate for the control of FMD belonged to national authorities and, at an international level, to regional and international organis ations such as AU-IB AR, F AO and OIE.

Vision statement

Taking the draft vis ion s tatement pos ted on the website as the s tarting point, a s eries of revis ed drafts were developed during and imm ediately after the works hop. This process eventually res ulted in a vis ion s tatem ent which was endors ed by the works hop participants :

Vision : A world in which livestock -b ased livelihoods, enterprises and trade can flourish unim peded b y foot-and-mouth disease

Rationale for vision statem ent: Although opinion differed at the Agra m eeting as to whether the vision s hould include a tim e-frame, the final vers ion does not include one: a feature s hared with visions for m any s imilar endeavours including the m alaria vaccine roadm ap. Clear tim e-frames do, however, appear in the s trategic goals . There was s trong agreement that the vis ion s hould be short, free of buzz-words and crafted to appeal to potential partners , including inves tors : this version is therefore s hort, s tates the benefits up-front and deliberately us es the word ‘unimpeded’, which was felt to be m ore realis tic than including a term s uch as ‘eradication’ in the vis ion.

Mission statement A m iss ion des cribes how the vis ion will be achieved. It s erves as an ongoing guide without tim e-fram e. The roadm ap’s miss ion s tatement is :

Mission : To estab lish and sustain global partnerships involving institutions in footand-m outh endem ic and free areas to develop, test and promote pack ages of tools needed for the successful control and eventual elimination of the disease in endemic settings

Rationale for m ission statem ent: Since the roadmap workshop decided that the focus s hould be on tools , the m ission provides an opportunity to explain the precis e role of the roadm ap and its contribution to the broader vision: it s tops short of implementation. It is cons idered that ‘global partners hips ’ im plies involvement of both

the public and private s ectors , without s pelling this out in full and m aking the m ission s tatem ent too long.

Strategic goals Definitions of s trategic goals vary widely and a variet y of s im ilar terms are us ed to m ean the s am e thing. For the pres ent purpos e s trategic goals have been defined as ‘specific objectives that are meas urable, tim e-bound and agreed upon, the achievem ent (or not) of which can be clearly determined’.

It is often useful to have m ore than one s trategic goal: one can expect to attain shortterm goals fairly eas ily - they s tand jus t s lightly above one's reach, while longer term goals m ay appear quite difficult.

The roadm ap’s s trategic goals are:

1. Between 2008 and 2012, to have developed, validated and promoted a set of

FMD control pack ages, b ased on the application and adaptation of existing vaccines, diagnostics and epidem iological and econom ics tools, that are fit for purpose and tailored to the dem ands of different endemic FMD settings

2. By 2015, through coordinated priority research initiated in 2007, to have dem onstrated proof of concept for new, im proved demand-responsive vaccines and diagnostics that will facilitate control and eventual eradication of

FMD in endemic settings

Rationale for strategic goals: The Roadm ap has adopted the concept of having two goals , one short to m edium term and one longer term. For goal 1, ‘application and adaptation’ implies us e of currently available tools but als o the tweaking of these tools to m ake them better suited to endem ic FMD s ettings . An im portant concept is that of developing, validating and prom oting packages of tools that meet the needs of different endem ic s ettings : s im ply m aking available vaccine was not considered to be enough – com plem entary diagnos tics and epidemiological and economic tools are als o needed for an effective control programme. ‘Develop, tes t and prom ote’ s tops s hort of im plem entation, which as agreed at Agra is beyond the Roadmap’s m andate. For goal 2 we have propos ed a meas urable, concrete goal – dem ons tration of proof of concept of new demand-res pons ive vaccines and diagnos tics . ‘Dem andresponsive’ implies the need for vaccines that provide a longer duration of immunity, a broader spectrum of protection and are less reliant on the cold chain, among the other priority criteria identified, without s pelling them out.

W hat are the endemic FMD settings that t he Roadmap shou ld ad dress?

The epidem iology and econom ics working group categorised FMD-endem ic s ettings into three groupings that would help to determ ine partner countries and ins titutions for the developm ent of FMD-control packages for different us es . These were:

• FM D-compromised cou ntries. Thes e are countries or regions of countries that are FMD-free, or ha ve in the pas t obtained freedom , but are s till at high ris k for one reas on or another. Exam ples are som e of the southern cone countries of South Am erica, s till vulnerable to re-infection from neighbouring countries in the region (s uch as Argentina), and countries of s outhern Africa, vulnerable to re-infection from neighbours (such as Bots wana) or from areas inhabited by Cape Buffalo (such as South Africa). Thes e would generally require rapid s tamping out akin to that carried out in Europe, but under quite different econom ic and infras tructural circums tances , which would affect the packages to be developed.

• FM D t hreshold co untries. Thes e are countries or regions that have active

FMD control programm es of one s ort or another, and are looking to im prove their FMD s tatus in order to enhance export opportunities or protect dom es tic production of milk and meat. These are likely to be conducting regular or periodic vaccination, and perhaps contem plating FMD free zones , or reducing ris k to facilitate comm odity trade. E xam ples include India, certain countries of

South Eas t As ia, and certain countries in eas tern Africa. Such countries are prim e candidates as roadmap partners as they will likely already be inves ting funds in FMD control already and are seeking better FMD control.

• Auto-sustain ing FM D cou ntries. Thes e are countries in which FMD is endemic, there is little in the way of inves tm ent in FMD control, and there are likely competing cons traints to the m ainly pas toral or sm allholder peas ant production s ys tems predom inant in the country. While thes e countries are of cours e s ignificant s ources of FMD virus to the world, and potentially s ignificant in terms of their poverty s tatus , infras tructural and res ource cons trains mean that they are unlikely to be able to make m ajor changes in their FMD s tatus in the next 5 – 10 years , and s o m any not be s trong candidates as roadmap partners under Strategic Goal 1.

THE W AY FO RW ARD

Enthus ed by the progress m ade in the works hop, and the multi-dis ciplinary and m ultinational contributions made to developing the outputs of the works hop, initial dis cuss ion in the las t works hop sess ion centred on defining what ins titutional m echanism options would m aintain the m omentum , enthusiasm , creativity, vis ion and coordination that had been achieved by the roadm ap process . The following is a s ummary of the ke y hallmarks of s uch a mechanism that em erged from a plenary dis cuss ion of all works hop participants :

• The m andate of the Global Roadm ap for Im proved Control of FMD in Endem ic

Settings is the development, tes ting and m aking available of packages of tools for F MD control. The m andate is not the control of FMD its elf, the responsibility for which lies with countries , regions , regional organis ations (s uch as the SE As ia FMD Programm e, and PANAFTOS A, for e xam ple) and international organis ations (s uch as FAO and OIE). • An ins titutional m echanism to catalyse and facilitate effective partnership and communication between the many international contributors to the Roadm ap m andate would greatly increase the chances of its success . • His tory s ugges ts that having a “cham pion” from am ong the group involved in the ins titutional m echanism will optim is e the catalytic and facilitation roles . • Such a mechanism s hould not “redis cover the wheel”, re-invent or compete with exis ting ins titutional m echanisms , complicate exis ting partnerships , nor be

“top heavy”. • Such a mechanism s hould draw on exis ting partners hip m echanisms within the field of FMD res earch and control as much as possible. • Such a mechanism s hould have both an “action” element (the facilitation, and in som e areas coordination, as pects ), such as a sm all functional Strategic

Steering Group as recomm ended by the People and Process team at the works hop, and an “overs ight” group (s uch as an Advis ory Board) that ens ures repres entation of key s takeholders in FMD-endem ic settings , as well as researchers and international bodies . • The three currently active m echanisms considered to be highly relevant to the

Roadmap are: o The Global FMD Research Alliance (GFRA). This is primarily a research partners hip of the high security F MD laboratories in the USA, Canada, UK and Aus tralia, but also includes ILRI which has cham pioned the endem ic FMD roadmap process as part of the GFR A’s Programm e 2. o The FAO European Commiss ion for the Control of FMD (EUF MD), bas ed at FAO headquarters in Rom e. o The Coordinated Res earch Programm e (CRP) m echanism of the FAO/I AE A Joint Divis ion, bas ed in Vienna. o It was concluded that together all had a lot to offer to the roadm ap, but in their current form and with their current mandates all would be required to im plem ent changes in order to s erve the m andate of the Roadmap. • The general consens us was that the GFRA was in the s tronges t pos ition to play the catalytic and facilitation role under its Programme 2, with s ome qualifications

o Programm e 2 m us t widen its repres entation to include other laboratories in both FMD-free and FMD-endem ic s ettings . o Programm e 2 m us t widen its horizons to include greater cons ideration of epidemiological and agricultural econom ics tools, and of the ins titutional partners in FMD-endem ic s ettings that can contribute to these. ILRI has been leading this component to date, and could continue with s uch a role. o Programm e 2 m us t partner effectively and urgently with both EUFMD and the CRP opportunities of the FAO/ I AE A Joint Divis ion to take advantage of funding and networking opportunities that thes e organis ations can provide. o Cons ideration s hould be given to the s tronger role of the pharm aceutical indus try in Programme 2, in particular the potential coordination role of IFAH, but als o the role of national pharm aceutical enterprises in FMD-endem ic countries (exem plified at the workshop for the case of India by Indian Immunologicals ). • A clear m ess age to emerge was that a great deal could be achieved with exis ting tools : if packages of s uch tools were developed, tes ted and prom oted, cons iderable progress in relation to control of FMD in endem ic s ettings could be achieved within a 5 year time-fram e. The Indian cas e s tudy s erved ver y effectively to reinforce this m essage. • Epidemiological and econom ic tools will play an important role in the exploitation of exis ting control technologies . • Some bas ic research will be required, es pecially with regard to imm unology and vaccine design but als o in areas s uch as epidemiological and econom ic tools . Such res earch is expected to lead to im proved vaccines that are better s uited to the needs of endemic countries : the availability of better vaccines , especially ones which provided longer duration and a broader s pectrum of protection and which did not need a cold chain, would pave the way for endemic countries to m ove towards FMD-free s tatus .

Key actions to take the initiative forward include: • Produce an electronic report of the Agra works hop and to dis tribute it widely to interes ted parties . A draft vers ion of this report will firs t be circulated to all works hop participants for comm ent before a final version is pos ted to the webs ite and dis tributed widely. A final report will be produced which com bines the Roadmap workshop report and the concept notes which will be developed bas ed on the works hop outputs (s ee final bullet, below). • Continue to us e the webs ite developed for the Agra workshop: www.endem icfm droadmap.net • Expans ion of the partnership bas e of the GFRA be yond the founder m em bers , i.e. the high s ecurity laboratories of the US, Canada, UK, Aus tralia and ILRI, s o as to facilitate the active involvem ent of endemic country ins titutions and als o the private sector, especially vaccine and diagnos tics m anufacturers . • Subm iss ion of a propos al to the Joint FAO/I AE A Divis ion of Nuclear Techniques in Food and Agriculture for funding to es tablis h a Coordinated Res earch Programme (CRP: see box below): if s uccessful, this would provide funding for s ubs equent m eetings and further network developm ent.

• Subm iss ion of a propos al to the EU to fund a follow-up m eeting in Europe in 2008. • Build on the EU-funded FMD initiative based at FAO headquarters in Rom e • Prior to the Agra works hop, an undertaking was m ade to the principal funder, the Wellcom e Trus t, that concept notes for priority res earch identified during the works hop would be s ubm itted to the Trus t and other potential funders within four m onths of the works hop, i.e. by the beginning of April 2007.

Building on the outputs of the Agra workshop, lead writers have been nom inated to write concept notes in the key areas : imm unology and vaccine des ign and epidem iological and econom ic tools . In addition a lead writer has been nom inated for the people and process es subject area to ens ure that outputs from this working group are incorporated into the other concept notes .

Each lead writer will form a small virtual working group to help with the drafting of the concept notes . The draft concept notes will be pos ted on the webs ite and all works hop participants will be given the opportunity to com ment on them before they are finalised. In addition to being subm itted to appropriate funders , the concept notes will be included in the Roadm ap report.

Stakeholder analysis for peo ple and processes

Sta k e holde r Pa rtic ipa tion CVOs Input i nto SSG

Input i nto defi ning research agenda

Provide Nati onal Research fundi ng

Funders – Charitable foundations Fund research Accumul ate criti cal m ass

T o bring in m ore Donors

M eeti ngs/ conference fundi ng

EU Fundi ng

Invol vem ent at all level s

FAO Host s SSG

Coordi nates regi onal acti vi ties

Provides fundi ng

Worl d Bank Fundi ng

Potenti al cham pion

Deveopment Banks: Funders IICA Asi an DB Afri can DB Inter-Am eri can DB

Pharm aceuti cal Industry Input from outset i n advi sory capaci ty

Opti on to pi ck up IPR ari si ng from CRP Inclusi on gi ves pri ority access to i nfrastructure, facili ti es and experti se Possi bl e 10% fundi ng of pre-competi ti ve research Possi bl e role i n SSG Wi ll benefi t from im proved Anim al Heal th industry Inputs i n to epi dem model s Di agnosti cs Industry Pi ck-up research outcomes Provide fundi ng through Royalties

Inform ati cs Industry Survei llance M odell ing Li vestock Industry Potenti al funders

Definite benefi ci ari es

Other Industri es: Earl y engagem ent essential Engagement at Nati onal /Regional level Learn lessons from South Ameri ca

Ai rl ine industry T ouri st Industry Retai l chain / supermarkets GALVm ed Parti cipate at SSG

Im plementers of late stage developm ent of products from research agenda ETPGAH Im plementer of research agenda that overl aps ET PGAH SRA Other orgs OIE AU ASEAN SEAFM D COSALFA/PANAFT OSA SADEC EU FM D Com mi ssi on (FAO)

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