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Minutes of GF-TADs Summary of the presentations, recommendations and group discussions

(Lahore, Pakistan, 25-29 August 2003)

26 August 2003

The delegate from Malaysia chaired the morning’s session on rinderpest.

1. S. Morzaria presented an overview of the GF-TADs (Global Framework for the Progressive Control of foot-and-mouth disease and Other Transboundary Diseases), which is an FAO/OIE initiative to progressively control epidemic diseases globally, with multiple objectives that include poverty alleviation, increase regional and international trade in livestock, and food security. FAO and OIE have prepared a draft proposal and are currently organizing a series of regional consultations to identify priorities for inclusion in the proposal. For Asia, currently two consultations have been held, one for South Asia and the other for Southeast Asia. The APHCA session was utilized to address the recommendations emerging from the two consultations and to develop future plans for proposal development and resource mobilization. The presentation appears on page 89-92 (APHCA2004/08).

2. P. Roeder presented the Global Rinderpest Eradication program, citing the epidemiological work that has been conducted on rinderpest. He then proceeded to describe the excellent and successful project on eradication of rinderpest in Pakistan. Pakistan has successfully eradicated the disease through strategic use of good quality vaccine and diagnostic tests and deploying the participatory epidemiological approach. He acknowledged the vision, and perseverance of Dr Raja and his team involved in the programme.

A plaque was presented to Dr Raja by FAO-APHCA in recognition of Pakistan’s contribution to rinderpest eradication. Dr Raja thanked FAO, IAEA, OIE and EU and his colleagues for the support accorded to Pakistan.

The second session was chaired by the delegate from Sri Lanka.

3. J. Lubroth presented the EMPRES programme and also described the global vision for GF-TADs and highlighted key components, particularly related to those with an international orientation. He emphasized that the GF-TADs was demand driven and promoted by FAO, EU and OIE. He also reported how the various international organizations were working together to address livestock sector development. He then proceeded to discuss the principles of EMPRES, namely: early waning, early reaction, enabling research and coordination. He then briefed the session on how EMPRES has operated throughout the globe. He emphasized the need to use epidemiological methodologies to identify the source as a means of developing rational disease control strategies. The report appears on page 97-102 (APHCA2004/08).

4. P. Roeder then presented the status of rinderpest in various countries in Asia. Myanmar, Lao PDR and Thailand have been free from the disease; he will work to complete sero-surveillance and apply for freedom from infection in 2004. Cambodia’s status has yet to be verified. China’s status is not known because it is not an active OIE member.

In South Asia, Nepal is free from infection, and India is free from the disease. India will apply for freedom from infection in 2004/2005, Bhutan is provisionally free from infection and applied for freedom in 2002 but needs to settle some OIE issues in order to reapply in 2004. Sri Lanka is provisionally free and will apply for freedom from the disease in 2003 and freedom from infection in 2004. Pakistan will apply for freedom from disease in 2006 and freedom from infection in 2007, and Bangladesh will apply for freedom from disease in 2003 and freedom from infection in 2005.

The status of various countries appears on page 103-106 (APHCA2004/08).

5. T. Fujita presented the activities of the OIE regional representation based in Tokyo, Japan. The activities of the regional representation focused on disease information system, FMD control, control and prevention of emerging diseases, standardization of veterinary medicinal products in harmonization of control methods and techniques and control of aquatic animal diseases. He then gave some inputs for consideration in the implementation of activities related to GF-TAD in terms of coordination and management of its operations. The presentation appears on page 107-110 (APHCA2004/08).

6. J. Edwards presented the activities and progress of the OIE SEAFMD Campaign. He focused on the need for regional coordination in the sub region. While there is a regional coordination in SEA, it needs strengthening. He proposed that a similar coordination model could be done in South Asia. However, regional coordination requires significant investment in terms of manpower and material resources. He then discussed the MTM campaign, an example of zoning for disease control. From there he proceeded to list the requirements to achieve an effective zoning for disease control. The presentation appears on page 111-120 (APHCA2004/08)

7. J. Crowther gave a presentation on the activities and diagnostic support that the Joint FAO/IAEA Division could give to control TADs. He listed the diseases, the kits that they are involved in promoting, validating and producing and explained the more general activities that IAEA is conducting. He then went into more detail concerning the work by IAEA on FMD. The presentation appears on page 121-146 (APHCA2004/08).

8. V. K. Taneja presented the recommendations of the South Asia (SA) consultations held at Ludhiana, India between 2 and 5 June 2003. The SA priority diseases are rinderpest, FMD, PPR and HS. The sub region recognized the need for a progressive FMD control programme with a defined timeframe. Due to the large area of the region, a zonal approach will have to be explored. Studies on the epidemiology of the disease in each country would have to be conducted as well as an economic impact analysis of the disease within the country and the region.

Other recommendations included the need for animal movement management, animal identification, relevant legislation, effective vaccination strategies, an FMD vaccine quality assurance agency, a regional FMD reference lab, creation of national commission on FMD in each country and SA Regional commission for control of FMD under APHCA. The need to involve stakeholders in all stages of planning and implementation was urged by the SA group.

Rinderpest was extensively discussed previously and all countries were committed to maintaining the free status on rinderpest. The report on recommendations appears on page 147-149 (APHCA2004/08).

9. C. Leowijuk presented the recommendations of the Southeast Asia (SEA) consultations held in Bangkok, Thailand last August 2003. The SEA priority disease list includes FMD, rinderpest, PPR, CSF and HS. The group agreed that countries should maintain the status of freedom on rinderpest and PPR and should explore assistance for Myanmar and Cambodia on this matter. More epidemiological studies as well as economic impact studies should be conducted on FMD, CSF and HS. In general, the group agreed to tap existing networks established in FMD control and other diseases. The report on recommendations appears on page 150-153 (APHCA2004/08).

27 August 2003

A. Delegates were requested to review the recommendations originating from the two separate consultations held in SA and SEA. The delegates from SA and SEA worked as two separate groups and came back with a modified set of recommendations. These are presented as separate handouts. Summary of discussions and key modifications are presented below:

1. The SA group listed FMD, rinderpest, PPR and HS as the priority diseases in the region. For FMD and other TADs it was recommended that a regional coordination unit under APCHA was needed for smooth running of the sub regional programme.

The SEA group listed FMD, rinderpest, PPR, CSF and HS as the priority diseases in the region. However, it also listed Newcastle disease (ND), Brucellosis and Rabies as problems in the region. The countries volunteered to draft the concept paper for Brucellosis and ND. Philippines and Malaysia will take the lead for ND and Brucellosis, respectively and will generate drafts within the next two weeks. Rabies will be referred to the WHO Steering Committee on rabies. A consideration for the future would be the inclusion of aquatic animal diseases.

A. Number of issues were discussed, the important ones among these are highlighted below:

B. For the next group session the following questions were posed:

The participants were divided into four groups, with each group comprising a mixture of participants from both sub regions.

The outputs of the four groups are summarized and will be presented separately. The following main issues were discussed:

The need for economic studies to consider the cost-benefit analysis related to TADs control in the context of poverty alleviation and trade opportunities was also discussed.

The research issues focused on the need for investment on an FMD vaccine. There should be training of people with research orientation specifically for FMD. Countries should try to cultivate and sustain research scientists in the region. Research should be done in this region since this is where the disease problems are.

The next session was facilitated by J. Edwards and the participants were asked to review the recommendations and use these as an exercise to identify potential large projects for each of the sub regions and develop key components for each of the identified projects. This exercise was designed to obtain greater clarity of the key issues in addressing TADs in the region. The participants were again divided into four sub regional groups to address these issues.

The following projects were proposed from the four groups:

South Asia: Regional project on the control of FMD and PPR

Southeast Asia: Regional project to accelerate the progressive zoning to control and eradicate FMD by 2008

Pakistan, Iran, Afghanistan and Central Asia

Establishment of a regional coordination mechanism for the progressive control of transboundary animal diseases in Central Asia - Afghanistan, Iran with involvement of Pakistan and China

The common components among the three proposed projects were:

Following discussions in a plenary session it was concluded that these were broad recommendations on the projects and more details need to be included and then a concept note needs to be developed for each project along the standard formats generally requested by donors.

GF-TADs need to be built on existing national programs. There is strong support for FMD and the other priority diseases listed.

28 August 2003

The final session on GF-TADs was a round table discussion, which was preceded by a presentation by J. Lubroth and S. C. Suneja.

J. Lubroth described ongoing activities related to GF-TADs, particularly emphasizing the existing regional networks and their role in the development of regional priorities. He also described a consultation held among representatives from USA, Canada, UK and Australia to discuss research issues related to TADs. He highlighted the research needs identified related to vaccines, diagnostics and epidemiology. The carrier state was one component that was considered important as part of epidemiological research.

S. C. Suneja briefly described a newly developed computer based Animal Disease Information System (ADIS) supported by structured sero-surveillance sampling frames for rinderpest in the first phase. In the second phase other livestock diseases will be included in ADIS.

S. Morzaria thanked the participants for their inputs in the consultation process. He outlined the next steps in the development of the regional component for GF-TADs. This would involve development of a concept note (CN) for the region. It was suggested that a CN would be developed by a small team of staff from FAO, OIE and two representatives from APHCA. This was accepted and a CN formulation team comprising India and Malaysia (Drs Taneja and Aziz) and FAO and OIE (Drs Morzaria and Edwards) will be involved in finalizing the CN.

The EU representative, Dr Dale informed the group that the EU funded project on TADs in Pakistan is viewed as a regional project and suggested that Pakistan take a lead to formulate plans for a regional coordination unit involving Pakistan’s trading partners Afghanistan, Iran and Central Asian countries.

The time frame for presenting a ‘business plan’ of GF-TADs to the donors was also discussed. J. Lubroth indicated that this was likely to take place sometime in December 2003. The meeting agreed that the CN for GF-TADs Asia would be prepared by end of November 2003. It was also agreed that there was a need to sensitize donors in the Asian region on current developments in GF-TADs. It was acknowledged that for GF-TADs to be successful APHCA needs to give it priority and actively promote it. In all donor consultations it was agreed that APHCA representative(s) should be invited to be part of a team that will also include representatives from FAO and OIE.

Global framework for the progressive control of FMD and other TADs

(Presented by Subhash Morzaria, FAO/RAP)

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GREP - Pakistan, a success story

(Presented by Peter Roeder, GREP Secretary)

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EMPRES and the Global Framework for the Progressive Control of FMD and other Transboundary Diseases

(Presented by J. Lubroth, EMPRES)

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Status of Rinderpest in Asia

(Presented by Peter Roeder, GREP Secretary)

Status of Rinderpest in Asia
(summary of Dr Roeder’s presentation)

A situation was described in which there is growing optimism that rinderpest has finally been eliminated from Asia. However, while only one endemic area of rinderpest is known to remain in Africa, the risk of a global resurgence of rinderpest will exist and vigilance must be maintained. Against this background the intention was to review the current status of accreditation of countries according to the OIE Pathway and to determine what action, if any, needs to be taken within a regional framework. The following table summarizes the outcome from the consultation.

Situation in Southeast Asia

Country

Status

Action need

Cambodia

Believed to be free from rinderpest for many years, no vaccination for more than 20 years

The 10 year rule could apply allowing application for Freedom from

Infection Situation to be discussed by GREP Secretary with OIE and assistance provided to Cambodia

Serum bank exists which could be used for serosurvey if required. Use of scarce animal health financial resources on rinderpest accreditation is not justifiable. International assistance will be required if specific active surveillance activities need to be undertaken

China

Believed to be free from rinderpest since 1953, no vaccination since 1955 except for one localised application in 1994 in Xinjiang; not currently an active participant in OIE

Complete serosurveillance and apply for Freedom from Infection in 2004 under 10 year rule. Promote China’s active participation in OIE.

Indonesia

Free from Infection

Maintain surveillance
Annual reconfirmation to OIE

Laos

Free from Infection

Maintain surveillance
Annual reconfirmation to OIE

Malaysia

Free from Infection

Maintain surveillance
Annual reconfirmation to OIE

Myanmar

Free from Infection

Complete serosurveillance and apply for Freedom from Infection in 2004; status of activities to be ascertained by GREP Secretary and a source of assistance identified if necessary

Philippines

Free from Infection

Maintain surveillance
Annual reconfirmation to OIE

Thailand

Free from Infection

Complete serosurveillance and apply for Freedom from Infection in September 2003

Viet Nam

Free from Infection

Maintain surveillance
Annual reconfirmation to OIE

Recommendations

Although progress in accreditation of rinderpest freedom is proceeding well it is essential that all countries in the region maintain commitment and progress until all countries in the world have been accredited free from rinderpest infection

i.e. until global eradication is assured. The situation needs to be constantly monitored and assistance provided immediately should progress falter. Maintaining vigilance against any possible resurgence includes diagnostic preparedness and must be maintained until the end. With limited resources, allocating them to accreditation of rinderpest freedom is difficult or even not possible for Cambodia and Myanmar to justify. However, ensuring that all countries achieve accreditation of freedom from rinderpest infection is a regional and global priority. Therefore, a regional initiative for the control of TADs should include rinderpest, ensuring that:

To achieve this will probably require specific assistance for Cambodia and Myanmar.

Situation in South Asia

Country

OIE pathway status

Action needed

Nepal 1

Free from Infection (2002)

Maintain surveillance
Annual reconfirmation to OIE

India 1

Free from Disease (2003)

Complete OIE Pathway
Apply for Freedom from Disease for whole country November 2003
Apply for Freedom from Infection 2004

Bhutan 2

Provisionally Free (1992) Free from Disease (2000)

Complete Pathway
Apply for Freedom from Disease 2003
Apply for Freedom from Infection 2005?

Sri Lanka 3

Provisionally Free (1999)

Apply for Freedom from Disease 2003
Apply for Freedom from Infection 2004 or 2005?

Pakistan 1

Provisionally Free (2003)

Apply for Freedom from Disease 2006
Apply for Freedom from Infection 2007

Bangladesh 4

last rinderpest 1958 last vaccination 1998

Apply for Freedom from Disease 2003
Apply for Freedom from Infection 2005

1 No specific action required other than to monitor progress and ensure that it is sustained in accord with the GREP timetable. These countries are on course to achieve accreditation of Freedom from Infection by OIE before 2010, in fact by the end of 2007.

2 Although officially acknowledged by OIE as meeting the criteria for Freedom from Disease in May 2000, full endorsement of the status is dependent on Bhutan’s renewing its membership. Bhutan sees little justification for this expense. If this problem is not resolved by Bhutan with OIE then action to resolve it will need to be taken up with OIE by the GREP Secretary. With limited resources and in the absence of a livestock export trade, pursuing the objective of accreditation of rinderpest freedom cannot be considered a priority by Bhutan.

3 Sri Lanka now intends to apply to OIE for recognition of Freedom from Disease in 2003. A first full round of serosurveillance has been conducted in 1997/8 (4,455 sera excluding the north-east) and sera collected for 2001 (3,000) of which 1,000 have not yet been tested. There are staff training issues which need to be resolved urgently for progress to be made. With this resolved it is likely that progress will be resumed allowing for application of Freedom from Infection in 2004/5. The situation needs to be monitored closely. With limited resources and in the absence of a livestock export trade, pursuing the objective of accreditation of rinderpest freedom cannot be considered a priority by Sri Lanka.

4 Bangladesh understands that declarations for Provisional Freedom from Rinderpest were sent to OIE in 2001 and 2003; however, these are not acknowledged by OIE. It is intended to make a definitive declaration in the next few weeks. Further progress will almost certainly require external support. This will need to be resolved by international/donor support.

Recommendations

Although progress in accreditation of rinderpest freedom is proceeding well it is essential that all countries in the region maintain commitment and progress until all countries in world have been accredited free from rinderpest infection i.e. until global eradication is assured. The situation needs to be constantly monitored and assistance provided should progress falter. Maintaining vigilance against any possible resurgence includes diagnostic preparedness and must be maintained until the end. With limited resources and in the absence of a livestock export trade, pursuing the objective of accreditation of rinderpest freedom cannot be considered a priority by Bhutan and Sri Lanka. Ensuring that all countries achieve accreditation of freedom from rinderpest infection is, however, a regional priority.

Therefore, a regional initiative for the control of transboundary animal diseases should include rinderpest, ensuring that:

Suggestions to the regional framework for progressive control of FMD and other TADs in Asia and the Pacific

(Presented by T. Fujita, OIE Regional Representation for Asia and the Pacific)

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Consultation for Asia on the OIE/FAO Global Framework for Transboundary Diseases - Resource presentation on foot-and-mouth disease

(Presented by John Edwards, Office International des Epizooties (OIE), Thailand)

Introduction

Sub-regional consultations on the OIE/FAO Global Framework for the Progressive Control of foot-and-mouth disease and Other Transboundary Diseases (GF-TADS) were held in June 2003 in Ludhiana, India and in July 2003 in Bangkok, Thailand, The aim of each was to identify the need for additional support through the GF-TADS process. The outcomes of these meetings are being further considered in a full regional consultation at this meeting being held in Lahore, Pakistan in association with the annual APHCA meeting from 25 to 29 August 2003.

In both the previous consultations Foot and Mouth Disease (FMD) was identified as a major priority and several proposals for additional support will be presented for consideration at the current meeting. The details of these proposals will be presented by representatives of their region.

This paper gives background information on Foot and Mouth Disease in the region and several of the key issues for consideration at this meeting.

Foot-and-mouth disease status, sources of disease and the main animal movement flows in the region

Southeast Asia

In Southeast Asia, there are OIE approved FMD free zones in Indonesia and parts of the Philippines (Mindanao and the Palawan-Masbate-Visayas island group). The last focus of infection in the Philippines is in Luzon Island and this is the object of a targeted eradication program funded with support from FAO/AusAID.

East Malaysia has never had FMD and is preparing a case to demonstrate its status to OIE within 12 months. The southern part of peninsular Malaysia has been essentially free of FMD and the occasional outbreaks have been successfully eradicated. FMD incursions have been more frequent in the five northern states of Malaysia and it is anticipated that the Malaysia-Thailand-Myanmar (MTM) Peninsular Campaign for FMD Freedom will result in a free zone including Malaysia and the southern parts of Thailand and Myanmar.

FMD is endemic in the remainder of mainland Southeast Asia, however, the prevalence and distribution varies according to the characteristics of the livestock industries, the geographical conditions and the level of control activity.

The major strains of FMD in Southeast Asia are types O, A and Asia 1. Type O topo-types are active in the region and these include the Pan Asian topotype, some of the original Southeast Asian topo-types and in eastern parts the pig adapted strain. New type a strains have been seen in Thailand and Malaysia in recent times and they are genetically distinct from previous strains and this has resulted in a need to change the strains used in vaccines in this area. Type C has not been seen since the mid 1990s.

The main spread of FMD in the region is thought to be associated with the movements of cattle, buffalo and pigs toward the higher priced markets in Bangkok and Malaysia. Many of these movements are illegal. The main sources are large scale movements from central Myanmar and Cambodia and smaller scale movements from Lao PDR and Viet Nam. Infected livestock products, eg suckling pigs for Chinese New Year, are also a potential source of infection. It is also thought that new strains such as the Pan Asia topo-type of Type O and the pig adapted strain of Type O have entered the region from PR China and particularly through the Upper Mekong river area and also along the border between Viet Nam and PR China. The pig adapted strain is active in the Philippines

South Asia

FMD is endemic in most parts of South Asia and has significant economic impacts. Type O is the dominant strain and both the Pan Asia topo-type and a recently emerged variant are widely distributed. Types A and Asia 1 are prevalent at a lower rate while type C is rare or absent.

The major source is thought to be movement of infected animals (clinical and carrier cases). Infected livestock products, people and vehicles are other sources. In South Asia relatively unrestricted movements of livestock are common and these include both local and long distance movements. Some of these follow well established traditional routes. Others are long distance movements often crossing national boundaries for sale and/or slaughter.

The main long distance movements described by delegates (Figure 1) included movements from the Punjab in the northwest of India to the northern states and also to the south of India. Movements also occur between India and its neighbouring countries Nepal and Bhutan. There are also large scale movements into Bangladesh for slaughter from India and Nepal.

Livestock movements also occur across the mountainous borders between PR China and India, Nepal and Bhutan. Movements of animals between South Asia and Myanmar are thought to occur along the borders of India and Bangladesh. There are small-scale local movements of animals in the mountainous areas. Larger scale movements occur when market prices dictate. Movements of goats to Sri Lanka from southern India are also described.

Figure 1. Major animal movement patterns in South Asia

Main issues for consideration

Regional coordination

Both regions have identified regional coordination as an important aspect for the future control of FMD. In the case of Southeast Asia, coordination is already provided through an existing Southeast Asia FMD (SEAFMD) Campaign.

The SEAFMD Campaign involves the coordination of FMD control by eight of the ASEAN countries and these include Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Thailand and Viet Nam. The programme is currently directed by an OIE Sub-Commission for FMD in Southeast Asia and is now half way through its second phase (Phase II). AusAID is the major donor for this phase of the campaign. It has been agreed that prime responsibility for the SEAFMD Campaign will be transferred to ASEAN for the next phase of the campaign. ASEAN has agreed to establish an Animal Health Trust Fund to assist in this process. The current funding for the campaign is approximately US$300 000 per year from the major donor, assistance by the OIE Japan Trust Fund and a variety of in kind contributions by Thailand the lead country for FMD in Southeast Asia, member countries and other stakeholders. This new direction is aimed to provide for greater long term sustainability of the campaign. Additional international donor funding will be essential to ensure a smooth and successful transition and this should be an important element of the GF-TADS proposal for the Asian region.

Regional Coordination for South Asia has been under discussion for some time and there appears to be strong support for the concept. The essential elements for regional coordination are commitment by the member countries, a spirit of regional cooperation and resourcing and where necessary additional resources from the international donor community. There are several issues that need to be resolved to ensure that a regional coordination function for South Asia can be established. These include clarification of the functions expected, the management structure and an integrated approach to funding and these are discussed below.

For effective regional coordination there is a need for some kind of regional coordination unit, staffed to provide the management, technical and administrative skills required. There are several models for consideration and these include establishment with a member country as host, under a regional organization such as SAARC, or under an existing Regional Commission of an international organization.

In any of these cases there is a need for an organization or commission that has the ability to establish an accountable fund and to employ and manage staff.

A regional coordination unit can perform all or part of the following functions according to the staffing and resources provided. The functions include working with member countries and other stakeholders to:

Strengthening laboratory networks

FMD control requires a good diagnostic capacity and this involves a capacity for investigation of field outbreaks followed by access to a competent network of laboratories to confirm the diagnosis and to characterize strains. In both workshops it was recognized that this requires a World Reference Laboratory (WRL, Pirbright) supported by a network of regional reference laboratories (RRL). In turn these need to be linked in each country to a national laboratory system where initial FMD diagnosis can be carried out.

In Southeast Asia, ASEAN has agreed that the RRL will be at Pakchong, Thailand. A Biosecurity Level 3 laboratory has been built and it is now operating using local material and is waiting international evaluation of its biosecurity status before receiving its first international submissions.

At the South Asia consultation there appeared to be support for the concept of a RRL and India offered to host it. This will be the subject of further discussion at this meeting.

A RRL can perform all or part of the following functions according to the staffing and resources provided. The functions for either of the proposed RRLs could include:

Epidemiological networks

At both previous consultations delegates agreed that there was a need to build and strengthen epidemiological networks and to carry out studies to find the sources of infection and to understand the patterns of disease. This information is required in planning for disease control programs and also to direct activities once programs are implemented. There appears to be a need for skilled epidemiologists throughout the region. Overcoming this will require a combination of sharing of expertise, re-allocation of skilled staff, short term training, long term training within the region and overseas and strategic use of international expertise.

Zoning as an option for FMD control

There is evidence from many parts of the world that FMD can be controlled and eradicated provided that it is possible to implement a full package of control measures. Zoning has been widely used as a means of eradicating diseases in many parts of the world. It recognises that there are several phases in any campaign and these usually include a control phase to get the prevalence down to where an eradication objective would be feasible. The disease control measures applied in these phases will be different. Progressive zoning also recognises that a stepwise approach will most likely bring success and that in many cases it will be necessary to concentrate resources in the zones where there is the greatest chance of success and then to build on the successes.

Zoning involves a country, an area within a country or groups of countries eg MTM. Zoning has long been a method for the progressive control of animal diseases and for achieving access to trade. There is increasing interest in the potential for zoning to increase access to trade by taking advantage of the changes brought about by the emergence of the WTO, the Sanitary and Phyto-sanitary (SPS) agreement and changes to the OIE Animal Health Code. The importance of zoning was recently reinforced by decisions at the OIE General Session.

To achieve free zone status to the standards of OIE and trading partners may be difficult to achieve for many countries, particularly where there are many neighbouring countries and particularly when resources are limiting. The OIE guidelines for zoning require an applicant to provide evidence that they can achieve the following:

A set of principles to guide any future control or eradication activity in the Southeast Asia have been developed and these can readily be transferred to other regions. These include:

Using these principles, the locations for the establishment of zones for the long term control of FMD (10-20 years) have been identified. These are:

If successful these zones could be expanded and eventually would coalesce as progress was made.

It is recognised that some of the countries involved do not at present have the capacity or the resources to effectively establish and maintain these zones. If these zones are strategically placed to bring long term benefit to the whole region there needs to be a whole of region approach to building capacity and finding the resources required. It is considered that a long term strategic plan will be of benefit to the region because it is more likely to be successful and is more likely to attract the support of decision makers and potential funders. It can also give a focus to the substantial funding provided within the region by a range of organisations that are funding various aspects of disease control. It will need high level political support and co-operation with PR China, India and Bangladesh will be necessary.

The OIE Sub-Commission has endorsed the progressive zoning approach and agreed to the establishment of working groups to begin work for each potential zone. Funding will be needed for both the implementation and feasibility processes.

There was also strong interest in zoning in the South Asia consultation and zoning is an important aspect of the Indian national plan for FMD.

Recommendations from the mini-consultations

Southeast Asia

The FMD consultation was preceded by presentations on the regional coordination of FMD control through the Southeast Asia Foot and Mouth Disease (SEAFMD) Campaign, the progressive zoning approach to FMD control as endorsed by the OIE Sub-Commission for Foot and Mouth Disease in Southeast Asia, progress with the transition of the SEAFMD to ASEAN responsibility and country reports.

Delegates and observers were split into three groups to consider the critical gaps in the regional plans for FMD control and to identify proposals requiring additional funding for consideration by the GF-TADs. Following feedback from the groups a list of activities requiring additional support was compiled and this included some large scale regional initiatives and also many smaller scale activities. When participants were invited to assist in prioritization it became clear that FMD control and eradication requires an integrated multidisciplinary approach to be effective and specific small scale projects in isolation are unlikely to be effective investment of scarce resources. For this reason the workshop agreed on two main proposals for recommendation to GF-TADs. These were aligned to agreed regional priorities and were underpinned by a need for a strong and coordinated capacity for epidemiological investigation and diagnosis. In particular the progressive zoning approach will initially require the capacity to undertake technical and economic feasibility studies and these will require very good capacity for epidemiological and economic analysis.

1. Strengthen regional co-ordination and co-operation by:

- Ensure resourcing to ensure smooth transition of SEAFMD to ASEAN responsibility

- Strengthen the laboratory network including WRL, RRL (designated laboratory at Pak Chong) and National laboratories

- Establish an epidemiological network involving regional and national nodes

- Accelerate the development of harmonized information systems for animal health and production.

- Creating linkages with countries neighboring the region e.g. PR China, India, Bangladesh

- Establish mechanisms to integrate all stakeholders (public, private and international agencies) as partners in the funding and delivery of global, regional and national programme

- Strengthen communication with all stakeholders

2. Accelerate the progressive zoning approach to the control and eradication of FMD in Southeast Asia by:

- Provide resourcing to complete the feasibility process for the establishment of FMD free zones according to agreed principles for zoning for FMD. This involves support for working groups and to carry out epidemiological and economic studies. These studies will build on existing broad scale knowledge of the sources of FMD and will for each potential zone clarify the patterns of FMD spread including the identification of internal and external sources of infection by investigation and modeling of patterns of movement of animals and the FMD virus transmission dynamics

- Increased resources to build capacity to deliver animal health services in countries with less resources (includes laboratory diagnosis, epidemiological analysis, delivery of field activities and vaccine quality control

- Review policy and implement effective animal movement management to establish and maintain zone status

- Implement practical and harmonized approaches to animal identification

- Enhance planning and training for emergency preparedness

- Targeted programme of communications and public awareness

- Where there are significant trade opportunities for pigs zoning proposals will also need to consider classical swine fever

South Asia

The FMD consultation was preceded by country reports and presentations on regional coordination and the progressive zoning approach to FMD control used in Southeast Asia. Delegates and observers were then split into three workshop groups to consider the critical gaps in the regional plans for FMD control and to identify proposals requiring additional funding for consideration by the GF-TADs. These groups were I - the northwestern countries including India, Pakistan and the western part of Nepal, II - the northeastern countries of India, Nepal, Bhutan and Bangladesh and III -the southern cone of India, Sri Lanka and the associated island groups.

The groups held several workshop sessions and provided feedback to the main group on FMD status, movement patterns for susceptible livestock and potential projects for consideration under the GF-TADs. The issues of regional coordination and the establishment of a regional reference laboratory were workshopped by the whole group.

The initiatives could be separated into several categories and these included those requiring national commitment, possibilities for regional collaboration and support including offers of support from India to its neighbouring countries. There were also suggestions for wider support and these were support for regional coordination, strengthened diagnostic capacity, zoning proposals and the need for increased epidemiological capacity and targeted epidemiological studies. These will be the subject of proposals for the GF-TADs.

Pakistan, Afghanistan and neighbouring countries in the Middle East were considered to be very important for the global control of FMD and a proposal to deal with these countries is necessary under the GF-TADs.

Regional initiatives proposed for FMD Control were:

1. Initiate a regional programme for the progressive control of FMD which is to be implemented within each country with a clearly defined timeframe. Since it will be difficult to launch a full scale program for the region as a whole or as a country as whole, it is desirable to have a well defined zonal approach as described by the OIE animal health code on the OIE pathway (freedom with vaccination/freedom without vaccination) to attain the ultimate goal of free status.

2. Undertake a detailed study of epidemiological status (generate the required data/subject to analysis the available data) of the different countries, and the region as a whole. This will help in defining the primary endemic zones and address the priorities for control.

3. In order to generate the required resources there is a need to undertake the economic impact analysis of the proposed control initiatives both within the countries and the region. This will be very beneficial to get donor support for national as well as regional control programs.

4. Since there is a great logistical difficulty in managing animal movement, within and between the countries in the region, the FMD disease situation is complicated. This needs to be addressed correctly by suitable means including legislations, quarantine measures, border management of animals, and animal identification schemes.

5. There is a need to share the information about the prevalence, distribution, movement and emergence of the disease along with the early warning protocols in place.

6. Considering the limited resources, and a large FMD susceptible livestock population in different countries of the region, suitable vaccination strategies need to be identified. For example, considering the use of monovalent type O vaccination as it is the most prevalent serotype, and vaccination of all species versus cattle and buffalo only.

7. There is an urgent need for the establishment of independent vaccine quality assurance agency to ensure uniformity in the quality of vaccine to be used.

8. To ensure FMD diagnosis in all the countries there is a need to establish a regional laboratory for FMD in the region. This will ensure the availability of diagnostics, assisting in establishment of appropriate laboratories where required, training of manpower, detailed characterization of field isolates, molecular epidemiology, selection of suitable candidate vaccine strains for the region, maintenance of the regional repository and collaboration with the World Reference Laboratory. The capabilities already available in India at the PDFMD (Project Directorate on FMD) of ICAR can be utilized for this purpose.

9. There is a need for the creation of a national commission for each country under the overall umbrella of a South Asian regional commission for the control of FMD. This will help in giving a clear focus for FMD control in the region. This can be under the auspices of APHCA or any other appropriate body agreed by all the member countries within the Region. Such a structure would have a stronger lobbying capacity to attract donor funding.

10. For the successful implementation of FMD control programmes within each of the member countries or within the region as a whole, participation and involvement of all the stakeholders (farmer groups, traders and livestock products, milk cooperatives, industry and other agencies) is essential.

Approaches for improved diagnosis and the development of vaccines to combat infectious diseases in animals (Food for thought and thinking for food)

(Prepared by J. R. Crowther, Animal Production and Health Section of the Joint FAO/IAEA Division, IAEA, Vienna)

1. Summary

This paper attempts to put emerging technologies into context with regard to their importance to developing countries. Often there is a lack of understanding of the actual needs inherent in managing and solving problems and an unrealistic assessment of the feasibility of approaches.

The progression of molecular techniques has been rapid since the development of the Polymerase Chain reaction (PCR). This allows molecular scientists to identify, characterise, copy, amplify and manipulate genes in a relatively simple way. The applications in all biological research fields have been enormous. The exploitation of the technology to devise new products and translate these to the commercial sector has also been remarkable. Molecular technologies are not so difficult to set up and therefore can offer developing countries access to a more competitive situation. However, developing countries must look at the apparent advantages offered in a different way. The immediate ‘hype’ of molecular biological science seems to offer an immediate solution to all problems, a sound bite to success. This often over-rides any of the real problems or needs associated with feasibility of introducing molecular technologies and their role. This can be very detrimental to more conventional and thoroughly practical methods, already available, which provide specific tools in the disease control area. It also might deflect resources entirely into the molecular field in terms of equipment, laboratory funding in general and particularly in training areas. This causes redundancy of staff, limits needed development in conventional techniques and polarisation of scientists into those with older (less glossy) and newer (molecular) camps.

Disease control in the area of diagnostics is now heavily dependent on more conventional techniques such as ELISA. This will not change and developments will centre using these in combination with more discriminatory molecular techniques offered by the PCR. A balance and parallel development is needed and this needs to be exemplified through advice from FAO about the feasibility and appropriateness of technology at the national and particularly regional level. This understanding requires increased knowledge by international scientists involved in developing countries as well as education of policy makers in developing nations.

Vaccines offer a particular challenge, where molecular science should provide many answers. The developing country may have a distinct advantage here but “vaccinology” needs to examine both the animal (immunology of target species) as well as the disease agent itself. This is a research-based science and as such is expensive and there is no surety of success. Developing countries should exploit links with developed countries to provide the ‘field’ genetic resource (endemic disease situation) in order to devise and test vaccines developed through molecular studies.

An understanding of the demographic, economic and infrastructural basis of a countries disease elements, is needed before decisions about developmental support, can be made. This, due to the massive competitive demands on ‘poor’ economies, is seldom easy and rarely attempted. The developing trade situation can act as a catalyst in this consideration since International assurance (e.g. of the disease status) is now a key issue if links are to be made. Without a realistic analysis, we shall continue to react to developments in a knee jerk way and inject molecular science through small specific projects, without any attention paid to the real impact nationally. It should be a policy for FAO to deliver help only for projects dealing with the wider national issues. To do this there must be far greater cooperation between all agencies involved in project support. In order to do this a new system of delivery should be considered. This should also try and identify who should pay for developments since increase in wealth through trade usually means that commercial concerns benefit directly, the dispersion of increased wealth therefore remains a political problem better examined at the beginning of a developmental cycle than after.

2. Introduction

The developmental state of any country is crucial in catalysing the national commitment to controlling and eventually eradicating diseases.

2.1. The possibilities of increasing trade, restricted by a country’s contamination with disease agents, is probably the major stimulus in facilitating better planning and resources for control. The relative importance of diseases in terms of time and geography, is very varied. The political dimensions involved in disease control can take a high profile and should not be dismissed lightly. There can be no ‘sound bite’ to cover easy solutions merely through the introduction of any technologies. Control requires a complete package of good veterinary infrastructure, reporting systems, sample submission, laboratories with trained staff, validated methods, epidemiological units able to plan surveys, vaccination teams, etc.

2.2. The most relevant problem facing any plan to control livestock disease is unrestricted or poorly understood animal and animal products movement. Although this dogma is the first and last point always made in meetings at any level, it is always side tracked because of the apparent enormity of the problem. Without attention to this area, most interventions, including those considered in this paper, are a waste of time. This is exemplified by foot-and-mouth disease control world wide.

2.3. Comparing control measures aided by vaccines and diagnostics, with those involving identification and effective manipulation of gene (s) for increasing resistance and tolerance factors against disease, it must be recognized that the possible benefits involve a completely different time scale. Neither is it possible to divorce the two areas completely and specific diseases and concentrations of different animals in different countries with different mixes of livestock are obvious factors influencing the successful exploitation of methods. This type of consideration is crucial in deciding where efforts should be made by individual countries in terms of resources and short, medium and long term planning. The cost benefit of one, or another, or a combination of approaches, should always be borne in mind and calculations independent of political consideration should be made to allow best advice.

2.4. Countries should strive to cooperate at the regional level. Regional co-operation is vital since diseases are transboundary in nature and may involve highly mobile vectors. Approaches in one country can severely effect another’s efforts. Regional projects should be the main support target for FAO. They have get advantages in promoting understanding, administration, planning and transparency.

3. General background

There are many initiatives by FAO who produce information and implement projects concerning disease control. Although the basic units for success are available including considerations of veterinary infrastructural requirements, disease reporting systems, contingency planning, epidemiological units, systems for data retrieval and analysis, vaccine campaign advice, sero-monitoring and surveillance systems, provision of and validation of kits, laboratory guidelines, accreditation guidance, training, expert visits.

It is however, difficult to achieve the complete package of measures in countries necessary to allow a successful approach to disease control. FAO are committed also to reacting to emergencies in terms of providing expertise, vaccines and laboratory support. Requests for emergency aid are the last thing that any disease managers want since it is an admission of failure on everyone involved. In order to achieve a better success at prophylactic measures rather than fire brigade activities, it is necessary to stimulate far better planning and awareness of the importance of livestock disease generally. This may mean an increase in staff by FAO and far greater cooperation between donors to reduce duplication and confusions of efforts.

3.1. The FAO indicate that ‘Sustained production of livestock is impossible unless effective measures are in place to guarantee animal health through exclusion and/or containment of transboundary animal diseases and serious pests as well as through health management’. Some diseases (zoonoses) may cause public health problems where they can be transmitted to humans; they also may have unfavourable environmental consequences, e.g. when wildlife populations are decimated. Diseases also cause avoidable pain and suffering to many animals.

3.2. The FAO support the policy of helping member states in the control of major livestock diseases.The Emergency Prevention System for Transboundary Animal and Plant Pests and Diseases (EMPRES) - aims at controlling transboundary animal diseases. As for the emergency prevention system for transboundary animal diseases, FAO plays a catalytic role in monitoring and coordinating regional and international efforts and providing technical advice and other forms of support to member countries.

3.3. Evolving disease control strategies in any country involves consideration of the genetic nature of the disease agent as well as that of the host target. The major strategy of the agent is to exploit its inherent high rate of replication, so that mutations are selected to overcome host defence mechanisms. This selection process vastly outweighs any of the possible genetic attributes of the far more slowly reproducing hosts. Strategies affording protection through breeding and manipulation, have therefore, to accomplish a more generalized protective cover. There are examples of such gene-advantaged animals, but the challenge data is most often singular and no account taken of the multiplicity of agents available to infect an animal independent to the gene(s) introduced.

3.4. There is a deep lack of fundamental knowledge on immunity mechanisms in livestock, however there is progress through genome mapping projects in chickens, cattle, pigs, sheep and goats, which may help. It might be concluded that the simpler the agent of disease in terms of genetic material the more risk there is to livestock e.g. virus diseases which are all the OIE list A pathogens! Where there is some stability in larger genomes of disease agents or the diseases are less pathogenic, there may be more chance of success in the breeding in of ‘protective’ features.

3.5. Vaccines are usually a direct intervention between the agent and livestock through inducing humoral or cellular immunity. As such the constant monitoring of strain variation is necessary and possible, through conventional and increasingly by molecular ‘diagnostic’ methods (molecular epidemiology), to take account of changes in the field affecting vaccine efficacy. This idealised situation takes account of the variability of the agents in the field for a specific disease. The fact that more than one vaccine can be used against different agents also gives the possibility to increasing the spectrum of protection. This is not as easy to produce in a genetic way in breeding.

3.6. Diagnostic approaches involve both serological and the newly highly regarded molecular techniques. The training element cannot be underestimated. Training on a continuous basis with attempts at larger scale training courses for participants from many countries should be a policy for both FAO and national concern. Such training should emphasise always the relationship between serological and molecular techniques as well as the advantages and drawbacks inherent in the use of the methods. Such training will build up expertise both in the technology as well as resistance to the “immediate solution” preaching of the total and singular molecular package as a certain answer to all diagnostic needs.

3.7. Associated with 3.6 is the developing technology gap. A gap of understanding between scientists who diverge due to the introduction of technologies e.g., molecular. This is observable in countries which have developed some potential to exploit products with the resources to set up molecular Institutions. Such Institutions suck in funding at the expense of the established and worthwhile technologies, which do actually provide adequate tools to perform diagnostic tasks. This sets up a divide centred on resource management between the more active field workers and the more showcase research oriented few. The split between the two camps should be avoided through planning tasks rather than assuming that technology per se is a solution in itself. Training then should be clearly identified within a total plan for any country and FAO should certainly evaluate requests for training in the light of overall national development needs regarding animal health.

3.8. Vaccines and the technology surrounding their development and production, prove a very difficult area to assess generally. Development involves conventional approaches as well as all the possibilities of genetic manipulation (below) and thus, requires extensive knowledge e.g., of animals’ immunology, gene manipulation, adjuvant use, delivery systems, large-scale production, testing and certification (quality and safety). Thus, any serious national production usually has to be commercial. Commercial companies, addressing vaccine as a product for sale, identify only areas where there might be a profit. So their estimation of markets may vary considerably from the needs of regions. Even current highly purified FMD vaccines are barely profitable. As with the diagnostics, the vaccine market is highly fragmented. Development of vaccines for some important agents for use in developing countries is non-existent and coupled to the poor research training and facilities in such countries, ensures that no successful tool can be developed to aid control. The high cost of registering vaccines is also a limiting factor in their production in developing countries. This also sometimes stimulates bad practice where national vaccines are attempted. Some vaccines are more applicable to exploitation than others. Scaling up ‘genetically’ associated vaccines may be very difficult whereas the more conventional (ideally attenuated vaccines) are relatively easy to prepare (hence the success of rinderpest campaign and the development of the attenuated PPR vaccines). The FAO should attempt to put in place resources to help research into developing country requirements with regard vaccines and train people to have the necessary skills to perform good research.

3.9. Diagnostics involve the use of defined reagents either in the laboratory or in the field situation. This can be extended to the supply of kits. This whole area is beset with problems of validation. The measurement of the diagnostic sensitivity and specificity is a nightmare let alone the bad use of good reagents by poorly trained staff. The production of kits of good quality with robust reagents, is difficult enough, but the distribution and sustainability of kits is a nightmare. Again there are few candidates for profit in the diagnostic area to push companies to produce and distribute kits. This applies to both serologically based and molecular based approaches.

3.10. Reference laboratories for conventional and newer technologies are simply not adequate in the main to provide a useful service in the diagnostic or vaccine control areas. Although many organisations support the concept including FAO and ascribe a title to that end, there is little practical help in defining, maintaining, validating or using such Reference centres, as they should be. Projects to support the proper setting up of such reference laboratories to ISO-accreditation levels should be supported by FAO through training, advice and political negotiations to help sustainable funding. The exact role of any reference laboratory has to be defined from the start. National and Regional acceptance is of course vital in sustaining the centres. The FAO should take a more active part in setting up of quality laboratories and increase contact with other organisations charged with funding and management of diseases (EC, WB and OIE).

4. Opportunities

This section will deal with the reality and potential of newly developed methods for the examination of disease agents and their effects on animals to allow better control and diseases. Complimentarity with existing techniques will be examined. It is vital that established tests are not disregarded because of the need to follow a scientific fashion. The co-existence of technologies is vital to ensure that tasks in a plan can be completed. It will also examine new approaches to vaccines, again contrasting approaches to the conventional methods.

4.1. The appropriateness (feasibility, cost, cost/benefit, training needs, facilities) of the approaches will be discussed to provide better judgment criteria for countries which are considering supporting for disease control. It must also be realized that there are two spheres for the exploitation of technologies in the research and applied areas. It is clear that “advancement” of research is more and more dependant on molecular (genetic) techniques. The spin off, or aim of research, is to develop better diagnositics and vaccines. This spin-off does not happen by accident and must be planned in the context of what is already available and what is ultimately specifically required by a country (or better a group of countries). It is not good to re-invent the wheel. It is good to apply science in areas which are most relevant to countries needs and where there is likely to be little competition from more developed countries.

4.2. Because molecular techniques offer very rapid manipulative methods to create new products, there is a vogue to build up Institutes to produce novel reagents seemingly for the sake of invention. This is not appropriate for many countries and while recognizing the freedom to allow scientists to fiddle in corners, it should be apparent that applied science is necessary to better allow developing countries to achieve stability in economic terms. The responsibility of FAO and like organisations is to guide scientists and administrators to the best pathways for utilizing techniques to solve immediate problems. This requires good plans to be produced and evaluated. Planning by countries within the context of overall developmental needs is often very bad. Here the FAO may be as guilty as any other in ignoring planning for the sake of political leniency.

4.3. Examples of approaches to technology transfer will also be given to illustrate difficulties. An attempt will also be made to cost the various activities necessary to set up newer technologies and estimate their impact. This will be a view from the Joint FAO/IAEA Division (AGE) in Vienna, charged with technological aspects of FAO.

4.4. Diagnostics

4.4.1. Ideally diagnostics employ methods which allow:

4.4.2. Diagnostics can be used in ideal situations:

4.4.3. The need and location of where tests are to be done are related to the planning of any country, infrastructure, lines of communication, reporting system, and taking and transportation of samples. These areas alone would require extensive coverage but are amply documented in many of the initiative from FAO and Joint FAO/IAEA Division. Thus, the merits of technologies have to be judged according to the needs. Certain advancements offer tremendous advantages to more remote testing, whereas others have to be regarded as complimenting only existing techniques. The ability to perform research offers a new dimension to the possible roles of Reference laboratories and this is discussed below.

4.5. Existing diagnostics

A very brief review of existing diagnostic methods is necessary before exploitation of newer technologies is discussed. This again should alert the reader to the possibilities of using existing technologies as well as newer ones to solve problems. Often the technologies are totally ignored or made redundant through the lack of maintenance of equipment. This is most obvious in the fields of microscopy (a large number of microscopes have been provided worldwide for fluorescence techniques which are useless for want of new objectives etc.). Many technologies have been introduced to countries requiring various equipment supply and training.

4.5.1. The most potent force in diagnostics in the past 30 yeas has been the Enzyme Linked Immunosorbent Assay (ELISA). The ELISA will remain a major technique since it fulfils the sensitivity criteria required for most testing. A great deal of technology transfer has taken place e.g. supply of ELISA readers. Many kits are available and in fact ELISAs form the large majority of prescribed tests for the OIE List A diseases. As such countries will be obliged to use the techniques to fulfil the required criteria under WTO rules. Unfortunately the levels of training required for countries to fully exploit the potential of this type of assay to develop tests, is poor and it thus it is woefully under exploited.

4.5.2. List 1 below is the easiest way to sum up other “conventionally” accepted tests available. Included are some surprises with regard to nuclear techniques* since they have been used for over 25 years.

4.5.3. One major consideration of all tests is the use of radioactivity. This is becoming increasingly difficult from legislative direction and most techniques now tend to develop alternative markers to assess activities.

4.6. Newer technologies in diagnostics

4.6.1. The most recent advances in molecular biological and other instrumentation technologies have been advantageous in improving diagnostic potential (and for the improvement of vaccines). Relevant biotechnological advances from product development and better research to improve understanding of diseases agents can be highlighted. These are genetic engineering (molecular biological advances); hybridoma technology and large scale (industrial production) of tissue culture; improvements in adjuvants and delivery systems for vaccines and molecular modelling for designing active anti-disease agent (particularly viruses) pharmaceuticals.

4.6.2. These improvements are a positive exploitation of the fundamental basic research into both the pathogen and also the host (e.g. better understanding of the immunology, allowing a better understanding of the mechanisms of pathogenesis) and the needs driven application of this research. Research then is the key to further development, and FAO should wherever possible further basic research into developing relevant, appropriate technologies as tools for developing countries. Advances also in other technologies are relevant, in particular the performance of computers in collecting, analysing and storing data and developments in instantaneous communication.

List 1. Conventional techniques

Tissue culture

Neutralisation testing

Compliment fixation

ELISA

Haemagglutination (HI) and inhibition tests (HAI)

Immuno histochemistry

Microscopy (including fluorescence)

Electron Microscopy

Poly acrylamide gel electrophoresis

Nucleic acid hybridization*

Immunoblotting*

Restriction Endonuclease mapping*

4.6.3. The massive leap in the ability to manipulate genomic information is linked absolutely to the development of the core Polymerase Chain Reaction (PCR) technology. This is the fundamental in most developments involving genes. Although, for the purposes of clarity, the vaccine and diagnostic sides are divorced, the technologies exploited are inter-related. List 2 summarises ‘modern’ approaches which are more recent to aid diagnosis. A list is most useful since there is a large amount of data to review. Most pertinent technologies will then be more extensively described.

List 2. Technologies to improve diagnostics

I. DNA manipulation (PCR enables this)
a. Expression specific proteins for use as diagnostic reagents. Expression. Systems: E.coli, yeasts, mammalian cells, Baculovirus
b. Gene deletion. Linking diagnosis to vaccine used. Differentiation of vaccinated and infected animals, e.g., Pseudorabies vaccine

II. Polymerase Chain Reaction. Basic systemsa.
Amplification of genes
b. Rescue and amplification from samples (RNA and DNA viruses)
c. Detection/differentiation of genes with specific primers. Multiplex to assess many parameters disease complexes
d. Rapid sequencing and comparison of products-differential diagnosis/confirmation
e. Molecular epidemiology
f. Portable PCR machines

III. Real time PCR (biggest developing area)
a. Direct detection of products.
b. Massive expansion of technology. Fastest growing research area
c. Multiplex to assess many parameters disease complexes.
d. Robotics (genome projects). Automation for high volume testing.
e. Expensive start-up costs

IV. DNA
a. Hybridization reactions.
b. In situ hybridization in diagnosis
c. Restriction endonuclease mapping-comparison of strains

V. Synthetic proteinsa. Peptides identified and produced as reagents for diagnosisb. Epitope characterisation.c. Pepscan, phage libraries

VI. Hybridoma technology -Monoclonal antibodies (Mabs) (Reduction in efforts in last 5 years)
a. Large supply Mabs from tissue culture
b. Production of defined product for use in assays to detect antigens and antibodies (ELISA). Improved specificity and sensitivity over polyclonal serum based assays. (standards easier)
c. Panels of Mabs for qualitative comparison of strains. Rapid differentiation between and within closely related strains
d. Production of Mab escape mutants to allow characterisation of antigens. Characterisation of epitopes at molecular level
e. Paratope profiling (determination of antibody spectrum)

VII. Biosensors (many systems with few useful developments)
a. “Instant” measurement in a single instrument
b. Pen side possibilities
c. Strong developments for diagnosis and environmental monitoring

VIII. Penside tests (successful, requires research base for development)
Dip stick technologies. Rinderpest, PPR, FMDV antigen detection

IX. Instruments
Rapid measurement of various signals in immunoassays
Florescence polarization, Enzyme Linked Immunosorbent Assay (ELISA), bioluminometry, chemoluminescence.

X. Availability commercial reagents/equipment
Restriction enzymes, DNA polymerases, reverse transcriptases, labelled bases, conjugated antibodies (enzymes, gold particles, fluorescent markers), dig-labelling, cell culture, affinity purification, cytokines, MAbs, microtitre equipment, thermocyclers. KITS, PCR. PCR/ELISA
Allow sequencing, labelling, oligonucleotide primers, antibody production (including MAbs)
Primers. Many Enzyme Immunoassays (virus diseases swine, ovine, bovine, poultry, fish, dogs, cats).

XI. Services
Sequence data banks/host and agent. Sequencing.Out-sourced testing. Training. Comparative data accessible to all. PCR products sequences cheaply.

XII. Computers
Data collection, analysis, storage, communication of results. Databanks of sequences. Essential in sequencing and comparative studies relating large amounts information. Essential as instrumentation “brain”

The list illustrates the width of possibilities and as such is complicated. The appropriateness of any technology has to be examined case by case. It also illustrates that serologically based methods certainly have their place beside the molecular methods. Great emphasis is placed on the PCR. Laboratories able to perform this assay should also be able to perform serological techniques. Screening tests followed by more confirmatory tests are a good principle to examine. Tests also have to be considered where certain vaccines are to be used.

4.7. Diagnostics technology transfer in practice

4.7.1. The Joint FAO/IAEA Division in Vienna has had a long history in technology transfer of diagnostics. This includes the ELISA as well as more recently the PCR technologies. The transfer, once again, cannot be simply regarded as one of providing reagents. Training was found to be the most vital element. This includes all aspects of laboratory practice and more fundamental scientific information (often found to be very weak). The technology was also transferred within the context of projects, the technologies providing the tool to obtain data on which decisions could be made. As such, the whole package, from sample taking, to analysis and processing of data, to action, has to be considered. Effective use of technologies only comes through the completeness of the plan. A reiteration then, but one so fundamental that it may be said again, several times. The responsibility of FAO is to guide countries. Another strong feature often not considered is the counterpart Institution and individual’s roll.

4.8. ELISA

This transfer has been a continuous operation for some 15 years. The need for ELISA was generated through initiatives mainly involving rinderpest, foot-and-mouth disease, brucellosis and trypansomoses. Here ELISA kits were being developed for sero-monitoring or surveillance and these operations figured in projects. The transfer has mainly been very successful with networks of laboratories in most continents able to perform good assays. Such networks also served to further validate assays.

The instrumentation to read ELISA has been remarkably robust with few problems of servicing. The peripheral equipment is also robust (multi channel pipettes, tips washing, incubators). Kits have been developed as well as allowing other ELISA systems to be run based on the experience of the scientists. Training (fundamental as swell as test specific) was always necessary (continuous) as new people came into various projects and as new initiatives (e.g. Internal quality control (IQC) and External Quality Control (EQA) were introduced. This approach has also allowed the development of local expertise and now many scientists from developing countries are capable of acting for their regions and Inter-regionally.

4.8.1. The cost of setting up ELISA technology would depend on the extent to which it was used and the present facilities in laboratories. List 3. illustrates the inherent costs. The figures are meant to approximate to what will be needed depending on the present levels of laboratory equipment and facilities as well as volume of intended work. The extent of samples examined, real price for kits and their exact make up (do they contain plates etc.) would depend on activities. Research activities would increase the miscellaneous reagent requirements and no costs for experiments have been made.

List 3. Cost in establishing ELISA

Item

$US

ELISA reader.

$6-8000

Computer.

$2000

Calibration plate

$700

Tips (per 1000) Needs depend on samples run.

$15

Microtitre plates (depending on kit supply) 10 and 80 samples per plate

$3-8 per plate

Miscellaneous reagents.

$1000

Pipettes (multi channel and single).

$1500

Storage for samples racks and containers.

$1000 per 2500 samples

Freezers.

$1000-$3000

Kits (variable).

$ 0.5-1.5 max per sample examined

Incubators/shaker*.

$3000

Distilled water apparatus* (or supply of good water).

$2000

Washer*.

$1500

Training (3 man months) independent.

$6-10,000

Books

$200

Training expert visit short-term home training course.

$ 1000

4.9. Kits

4.9.1. Coupled to the ELISA technology is the need for kits. Sets of stable quality controlled reagents and materials that allow a test to be made on samples to ascertain the antibody status with regard to specific antibody quantity or measure antigens characteristic of disease agents. This area is beset with massive difficulties. Although many kits are available the validity of their use in many cases is dubious. Validation per se is the subject of OIE guidelines and this needs reviewing dramatically. It is very difficult to define the diagnostic sensitivity and diagnostic specificity of kits. Often validation is mainly concerned with establishing the specificity with regard to samples from non-infected countries since they are produced in developed countries.

4.9.2. There must be a move to increase the process of validation to set standards to define the “fitness for purpose” of any assays, so that producers can justify kits against these requirements. A process for registration of kits is also needed and the FAO should consult strongly with OIE to establish such a system in line with the rigorous demands for certification of vaccines and in the whole accreditation process of laboratories. The main concern will be “who will pay” for this process, but without it there will be a continuation of the practice of kit supply to anyone, who will produce results (activity) with no quality control element (IQC or EQA) and who will supply data to disease management teams which essentially cannot be assured! To this end there is a meeting in November, 2002, in Vienna held organised by the Joint FAO/IAEA Division bringing together experts from FAO, FAO/IAEA, OIE, USDA, APHIS, to address the issues of veterinary testing in terms of redefining tests and examining a registration process.

4.9.3. Kits are also produced by commercial companies, Institutions that have a research base in particular diseases and locally produced (single laboratory kits). Often Institutions are suppliers of the specific reagents to companies. This causes problems in costing (too expensive for mass use in developing countries,), sustainability, distribution and ethics. An important initiative is to support sustainable kit production and distribution in developing countries. The Joint FAO/IAEA Division has been instrumental in helping Senegal assemble, and produce quality controlled kits for African Swine Fever. This is accomplished and kits sent. This is to be coupled to EQA rounds to assure quality. This initiative will be followed by a TC project (Regional S.E. Asian) to set up kit production for FMD in Thailand. This principle of sustainable, quality controlled production of kits for regions should be supported through projects from FAO and cooperation wherever possible with similar initiatives.

4.9.4. Associated with this initiative is the management of developing country laboratories to lead to accreditation. Standards have now been devised by IAEA through OIE to accredit laboratories. There are projects in 2003 in S.E Asia to accredit several laboratories under this scheme (IAEA, TC supported). It is vital that there is Regional co-operation to enable this process, particularly in the light of developing trading requirements. Again, FAO should have a policy of supporting all attempts to accredit laboratories. The same considerations for the use of PCR in diagnostics are necessary. Validation, reagent supply and accreditation are vital to the use of PCR, which is even more sensitive to poor practice in terms of contamination of labotratories, than ELISA methods.

4.10. Diagnostics and Polymerase Chain Reaction (PCR)

The potential of the PCR is that minute amounts of genetic material can be amplified millions of times in a short time, allowing the detection from samples of a single copy of a genome or part genome. PCR products can then be identified exactly through sequencing. The ability to amplify genomes allows genetic manipulation of genes which is the basis of the gene revolution. The very fact of the ultimate sensitivity of the PCR produces some of the problems in use of the method in routine terms.

4.10.1. The PCR amplification has many advantages:

4.10.2. PCR assays also have some limitations:

4.11. Transfer of PCR

Through its Co-ordinated Research Programme (CRP) the Joint Division has transferred this technology to many laboratories in Africa, and along with TC of IAEA, supported training through expert visits and workshops, supplied equipment and help set up diagnostic facilities in countries world-wide. Initially it was thought that the PCR technology would be very difficult to transfer, but this has proven false. So intrinsically the PCR can be transferred provided the parameters below are satisfied:

4.11.1. Important features of transferring PCR technology

1. The laboratory design in which PCR is used is correct. This is vital since contamination of minute amounts of genes can totally destroy the effectiveness of the laboratory to diagnose anything.

2. That training is given before any work commences on PCR.

3. That equipment is suitable and complete.

4. That strict laboratory practices are adhered to and rigidly enforced.

4.11.2. Cost involved in setting up fundamental PCR

Setting up a fundamental laboratory is the lead in to developing more expansive methods in PCR using the fast developing PCR technologies. List 5 indicates basic requirements.

List 4. Basic requirements and costs for PCR laboratory

Item

Cost $US

1. Laboratory refurbishment, 3 -4 small laboratory stations/areas needed

Local costs
(1-10,000 3500-8000

2. Thermocycler


3. Pipettes 3 sets x 3 Only for PCR stations

1500

4. Special tips (aerosol resistant) 10,000

3000

5. Enzymes for PCR

2000

6. Electrophoresis, power packs, visualisation of gels, recording, film

6000

7. Primers for agents

1000

8. Miscellaneous chemical s

2500

9. Gloves, lab coats

1000

10. Work stations (hoods) 2

3000

11. Refrigerators and freezers

2000

12. Labelled reagents* (Note supply problems)

2000

13. PCR tubes

1000

14. Micro centrifuge

3000

15. Training 3-6 man months per person (2 should be trained)

12-24000

5. Vaccines

Vaccines should be used in some control programmes to produce protection in animals, taking into account all the other control factors being employed. Vaccines are usually best supplied through commercial sources in terms of sustainable quality but often are produced more locally. Vaccines have to be regarded as expensive in terms of delivery and product, so should be used maximally in a well structured campaign. This requires all the veterinary infrastructural factors discussed earlier to be in place, including facilities to test the efficacy of vaccines and understand local strain variation which might affect vaccine performance.

5.1. More conventional vaccines may be put into groups:

1. Attenuated strains of live agents.

2. Crude preparations of agents, killed and adjuvanted.

3. Relatively pure killed agents, adjuvanted

5.2. The ability to manipulate genes through PCR has allowed research into new forms of vaccines. The list below illustrates the areas only and this document a canto go into great detail on each area. Some topics are expanded slightly.

This can involve:

5.3. Research requirements regarding all vaccines (vaccinology) require the ability to manipulate genes (PCR etc). Thus any developmental intentions should realise that a full-scale molecular biology laboratory is needed. The specific needs of a region to develop a required vaccine is best justification to perform research based on any molecular theme. The conventional vaccine approaches should be examined first and if found wanting, steps should be taken to develop newer approaches. These must involve studies on the more local aspects of disease agents. Research leading to a possible product is not the end of the story since scaling up (manufacturing processes) is just as vital and facilities to do this must also be available. It is clear that a consolidated approach to genetic engineering in the vaccine area is needed in countries, a focus of resources. Similar techniques for developing vaccines and products can be used by human and animal as well as plant molecular scientists and Institutions for research should not be competing for similar resources.

5.4. Another factor in development is the intellectual property surrounding genes and methods involved. This must be addressed before any developments are made, since it might be contested that developments are suddenly “owned” by others where a commercial advantage is seen. The FAO should take account of this and provide clear advise on developing any vaccines.

5.5. General features which must be considered in vaccines include:

1. The host species immunology, protective mechanisms (humoral or cellular).

2. The agent structure and function (antigenicity, pathogenicity, variation).

3. The vaccine formulation in terms of agent (whole attenuated agent, whole inactivated agent, large mixture of antigens, polypeptides, peptides.

4. Delivery systems for vaccines (injection, oral, water, aerosol, particulate, etc.)

5. Physical stability of vaccines (heat stability affecting efficacy)

6. Need (quantity vaccine required, scaling up, industrialisation).

7. Safety to animals and humans (reversion of attenuated trains, sterility, residues due to adjuvants).

8. Animal experimentation facilities to assess usefulness and safety of vaccines.

Genetic developments certainly help in some of these areas over more conventional approaches and may offer distinct advantages to developing countries.

5.6. Vectored vaccines

These vaccines use a “proven” safe and vaccine (the vector) as the backbone on which to graft new genes which express immunogens from other pathogens. Thus, vaccination with the recombinant induces a protective immune response to the new foreign inserted gene product. The most commonly used approach is to use a vaccine with a large DNA genome as vector to deliver foreign antigens. In early experiments vaccinia virus was used as the vector and the most successful product of this type is the vaccinia/rabies recombinant vaccine, which is now widely used in Europe and the USA to control rabies. This vaccine strain can still cause disease in a minority of humans. Safer versions of the vaccinia virus, for example the vaccinia MVA strain, are now preferred for vaccine development. This virus infects but does not replicate in mammalian species.

Poxviruses, such as avipox (canarypox and fowlpox), swinepox and capripox, myxoma have been applied successfully as vectors and are more suited for veterinary use as they target the homologous host species. In the case of rinderpest virus, both vaccinia and capripox recombinant vaccines have been produced both of which effectively protect animals against challenge with virulent virus. A recombinant Newcastle disease virus vaccine, using fowlpox virus as the vector to express immunogenic proteins from the Newcastle disease virus, has been licensed as a commercial recombinant vectored vaccine and a canary pox-based vaccine for feline leukaemia is now also available.

5.6.1. Many other DNA viruses, which have large genomes and are easy to genetically manipulate, have been used as vectors. Some vaccines have been produced for avian diseases using herpes virus of turkeys (HVT) as the vector. One such vaccine is used to protect chickens against both infectious bursal disease (IBD) and Marek’s disease. The smallest DNA viruses that have been used as a vaccine vectors are the adenoviruses. These in many ways are the most difficult to work with since some have oncogenic potential, they are highly species-specific and the genome is relatively small and can accommodate at the most two extra genes. However, an adenovirus recombinant has proved to be very promising as a potential vector for FMDV antigens. Another complication is that adenoviruses are very common in nature, thus, the replication of the adenovirus recombinant vaccine may be reduced or prevented by the original immunity of the animals, for example racoons are infected with canine adenovirus, or related viruses and the CAV-rabies recombinant replicated very poorly in this species. In addition adenoviruses, unlike poxviruses, are not very stable in the environment which makes them unsuitable for the vaccination of wildlife.

5.7. Virus-like particles

Virus-like particles or VLPs are virus particles that lack a functional or have a defective genome. They can be used as effective vaccines since they bind to the virus receptors on the host cell, enter the cells and induce an immunogenic response, without the dangers associated with replication, such as reversion to virulence.

5.7.1. For example four of the bluetongue virus proteins, namely the core proteins VP3 and VP7, as well as the two surface proteins VP 2 and VP5, when expressed together in a baculovirus recombinant can produce VLPs. Such VLPs are structurally identical to true virus particles and have been used to protect sheep against bluetongue. Their complex structure induces a better antigenic response than do individual virus proteins and they do not require adjuvants. A similar vaccine has been produced for African horse sickness, another orbivirus.

5.7.2. Other systems, for example the alphaviruses, Semliki forest virus and Western equine encephalitis, have been used to producing VLPs. Alphavirus replication requires the production of a subgenomic mRNA to produce the envelope glycoproteins and this region is substituted by foreign genes. The resulting virus in not able to form virus particles unless it is transfected into a cell which expresses the missing proteins, in which case it will produce VLPs. These can then be harvested and used to produce the vaccine virus which can enter and produce the foreign protein in new host cells but which cannot then replicate as infectious virions so they are safe to use as vaccines (Berglund et al., 1993).

5.8. DNA vaccines

Another breakthrough in vaccinology came with the finding that DNA itself could act as the vector and be used as a vaccine. This approach has shown great promise in animal model systems and is now a very active field of research for vaccine development. One of the most important features of DNA vaccines is their ability to induce a cell-mediated response through the production of cytotoxic T lymphocytes (CTLs). Because of this ability to induce a CTL response, a further development of this has been the prime-boost approach to a DNA vaccine expressing the immunogens is used to “prime” the immune system response, which is then amplified using a vectored vaccine, usually a vaccinia-based vaccine. This is approach is now being used in clinical trials of vaccines to protect against HIV and parasitic diseases such as Leishmania and malaria. This approach has also worked with an adenovirus recombinant as the booster cine to protect pigs against CSF.

5.9. Engineering and production of cytokines improved adjuvants

The development of vaccines also includes improvement in adjuvants. Here there is scope to research into system. The main functions of the adjuvant in a vaccine are to keep the antigen at, or near, the injection site and to activate antigen presenting cells to achieve effective antigen processing and interleukin production. There is currently great interest in developing new adjuvants, particularly those which act as ‘antigen depots’ providing controlled release of antigen over a long time span. Candidates include oil-water emulsions, liposomes, iscoms and biodegradable microspheres.

The immune system is regulated and activated by hormone-like cytokines. Immune responses to vaccines depend on complex cytokine mediated interactions and it is known that injection of certain cytokines can augment responses to vaccines. Recently cytokine genes have been engineered into live virus vectors enabling production of cytokines in a very localised environment. The expression of certain cytokines by vaccinia virus can selectively stimulate particular responses in mice following immunisation.

5.10. Edible vaccines

This approach to vaccine production is still at the early stages but promising leads have been followed to the point where proof of principle has been established. While it is obvious that using plants to produce immunogens would be very easy and cost effective it is not clear yet how easy it will be to vaccinate the target host species using the oral route.

The major practical constraint is that concentration of recombinant antigen in the plant tissues is normally very low and unpredictable expression levels are achieved, depending on where the transgene integrates into the plant DNA. Nevertheless, a strong immune response has been reported to occur in mice either fed or injected with an extract from an alfalfa plant engineered to express either the VP1 structural protein of FMD or an FMD-specific peptide fused to betaGUS protein. This is essentially using a plant to produce a peptide, which is known to induce a protective response to FMD Similarly, transgenes in potatoes which, express either the complete or part of the spike protein gene from swine-transmissible gastroenteritis virus, have been shown to be immunogenic when inoculated intraperitoneally in mice. A complication is the increasing public antipathy to the growing of genetically manipulated crops.

5.11. Cost involved in developing, producing and using vaccines

This is not easy to asses without dealing with specific situations. The cost of research can be regarded as high, although it is not necessary difficult to set up well equipped laboratories to do the work. The main costs are maintaining scientists (salaries and reagents), equipment, buildings. This could amount to sums in the high 100,000s of dollars per year.

A critical mass of scientists is needed to examine different approaches and the risk is that success is not assured. Even where there is a potential vaccine candidate, this then has to be subjected to extensive testing to prove efficacy, robustness, safety, and qualitative consistency. The risk is also that vaccines have to be scaled up and this requires a manufacturing infrastructure, again difficult to quantify. However, research findings can be “sub-contracted” to interested third parties and arrangements made to produce products with mutually acceptable, financial arrangements. Once again, it must be emphasised that cooperative efforts in regions offer a far better pay back than individual countries all competing in any particular line of research. Data shared and work planned together is a far better competitive signal and is logical since the disease problems are likely to be the same.

One of the advantages in research could be that different countries actually do have the genetic target of interest as a disease, and as such can trial the vaccine under field conditions. This product might have a much wider applicability and therefore, ensure a higher potential overall market value.

5.12. Conclusion on vaccines

5.12.1. Molecular methods offer unique ways of constructing novel vaccines. This development potential requires a relatively small outlay for equipment and reagents, but a high investment in training. There is little security in being certain that approaches will be successful. Research purely from the vaccine point of view is only part of the problem, investigations into the immunology of target species is necessary and lacking even in developed countries. Even where products look good from the small scale and animal experimental area, the need to register products is expensive.

5.12.2. Conventional approaches should always be looked at first where there is a more immediate need for control. The bad use of good vaccines must be avoided through good planning and coordination between field, diagnostic and epidemiological workers involved in disease control.

5.12.3. There can be a rapid utilisation of techniques developed in other laboratories (in developed countries) since genes and methods can be transferred easily. Care has to be taken where such exploitation is made with regard to patenting and intellectual property rights. The FAO should make this area clear and recommend procedures to help developing countries assimilate developments though furthering cooperation of developed and developing country scientists.

5.12.4. One point made before is that there is a danger that a technology gap will appear between the molecular scientists and those involved in diagnostics, certainly with regard to trained people able to test molecular products and constructs. The mutual understanding of both ends of the areas is necessary and this is particularly important in administrators decisions regarding the research and applied funding needed in developing (and developed) countries. This also includes those in charge of large scale “Aid” in e.g. WB and EC, who often favour molecular developments at the total expense of more feasible and useful conventional approaches, or who fail to fund elements necessary top evaluate molecular products. This is increasingly obvious in more rapidly developing countries e.g. Poland, Hungary, Czech Republic, who are tending to increase their ‘genetic’ research infrastructure but ignoring all the basic science. Ultimately this leads to frustration by scientists involved in molecular studies, who see a dead-end to their developments, a polarisation of funding which depresses the more basic scientist and a large waste of time and resources through ill conceived efforts to address the problems.

6.0 A perfect scenario-good planning

6.1. Basically a good plan will address the simple equation proposed, despite any other jargon imposed in management-speak. Such questions, if all answered will both justify the work, say who and where it will be done and address the massive problem, so often ignored as to HOW it will be done. The difficulty resides in the required DETAILS to say how and it is details that count. Senior management has a bad habit (including all organisations) of not bothering with details at all and passing them on and on to be picked up at the so-called technical level. At this point, the difficulties usually not foreseen become too overbearing to overcome and a bad project follows, diluted in intention (Why are we doing this?). The simplistic overview is admitted, but basically this is a politically unacceptable but practical truth. To avoid this a few simple questions should be in the minds of planners at all levels and all should be answerable at all times during the formulation and implementation of a project.

6.2. What?

This questions exactly what is trying to be achieved by the project. An overall objective then.

6.3. Why?

This tries to get away from any seemingly obvious reasons and catalogues all the countries demands. Planning may well come up with an answer that there is no, ‘Why’ and that a project is therefore not worth doing. Many projects fail simple because there is no collective agreement on the aims nor perceived advantages to one section or another. Planning of the Why then becomes as broader exercise as can be made and a national as well as hopefully regional exercise.

6.4. When?

This is critical to planning since a time frame will dominate assessment of any achievements. It will indicate when things are expected and a budget line.

6.5. Where?

Critical too since this examines resources, indicates needs, alters ideas in time lines (a new building may be needed). It sorts out the political wrangles that often takes place when resources become available to a project were previous parties, not involved in planning suddenly announce their superior abilities to do the work proposed better.

6.6. Who?

Linked to Where, this seems to be the major area where a project may sink or swim. The suitability of counterparts to understand, be involved with and fulfil tasks in a time bound and open manner is critical. Political considerations again have to be overcome before a project is instigated since orientation of other less suitable people has a bad effect on most projects. This also applies to trained personnel who then leave to take up e.g. commercial jobs through their newly gained expertise (this is more and more apparent in developing country scientists trained in PCR).

6.7. How?

Once there is a consensus about a project then all aspects have to be reconsidered in great detail, the HOW. This entails responsibilities being given to personnel involved in the various aspects of the project who can then estimate resources needed in time. This includes equipment, reagents, vaccines, training, laboratory refurbishment, data analysis methods, data storage, action plans etc. This can only be done when the previous 5 W are worked on. It is here that FAO can help most.

Armed with the principles and demand that good projects ONLY should be submitted to say FAO, the details can be fleshed out and resources (cash terms) allocated. This assumes that the criteria for a good project can be met by countries and this document may aid this process. Good planning required training and coordination. The latter requires a considerable political will which must be cultivated by all involved in food security issues.

7. FAO

8. Control of diseases - overall view

Figure 1. outlines the components involved in a countries consideration of veterinary matters concerning disease control. The black lines denote contact whilst the gray dashed lines and arrows denore a reporting flow of information or samples. Although this may seem complicated it indicates the various roles needed in a country, which must be complete to have a good chance of success. Letters have also been given to the various “blocks”, as well as numbers to question marks denoting important questions and linkages which may be absent. These are dealt with briefly now and the exploitation of molecular and conventional methods aiding diagnosis and vaccines are highlighted.

A. This means that disease is present in a country. Disease likely to be seen by C, D and E first.

B. Illegal movement is very common and causes movement of disease affecting both small farmers (C) and commercial concerns (F).

C. The small farmer with subsistence existence. Education needed and links with D and E essential. Links may be physical rather than telephone or other method. Clinics may be important sources at seeing disease, but may reflect later stages.

D. The veterinary helper. Probably the first to see disease or have it reported by (C). He/she is also part of other initiatives and can be trained to perform limited veterinary tasks. His work can be purposive (directed towards specific areas and diseases) as well as passive (routine, clinic approach). Contact rate must be high with C.

E. Field veterinarian. Responsible for routine and purposive (funded) work. Often poorly paid and in poor contact with administrative levels higher up (I, J, M). enside tests may help as wel as high technology communications devises in remoter areas. Sampling necessary and means to send damples to (H) or direct to (I)

F. Commercial operations relying on larger scale farming with higher profits. Links to governmental veterinarians and control can be weak (1? 2? And 3?) and hence not supervised. Disease often hidden increasing problems to (C) and other (F).

G. Veterinarians employed privately. Can be affected by (F) commercial values and lack of transparency.

H. Laboratory (clinic) able to perform some testing. Receive samples and pass them on to I or work with E to solve problems locally. Reporting to I important. Can use pen side tests as for E.

I. Regional well equipped laboratory able to make diagnosis, differential diagnosis and analyse data etc as shown. Molecular methods required. May be the site of epidemiology unit (J) in which case takes on duties shown for (J). Communication with a separate (J) and other national laboratories (K) vital. This is a key laboratory and must be supported through being able to receive, store, analyse and report data as quickly as possible to ((J) then to M), E, K. Should also be reported to by F.

J. Epidemiology unit sited in or separate to (I). Vital unit to design, plan, receive data, analyse data, prepare reports, communicate to field (I, H, E) an link strongly to policy makers in (M) to evolve contingency plans (*) and be in charge with M of action plans **. Links to International bodies also needed (N), as well as reporting and planning with other national laboratories (K).

K. Similar laboratories to (I) and epidemiology units to (J) in other countries. Rapid communication needed on daily basis informing of disease picture and early warning of diseases. Bilateral communication necessary as well as meetings.

L. A good knowledge by M of research Institutions needed to assess who does what with regard to developing products for diagnosis and vaccines. Strong relationship between M, N and J are needed as well as links to I. Training a key area for both veterinarians and researchers. Molecular methods needed.

M. Vital that relevant Ministries plan concerted action. Linkages made will all concerned in control. Contingency plans prepared and constantly updaed in light of Regional disease and activities. Policies towards training and research made and funded.

N. OIE role is to set standards and guidelines including serological and molecular methods. Validation and kits use can be examined in light of the trade issues. Reporting disease to OIE important.

Note

Gray arrows need examination. Reporting system is vital and means of rapid communication from field to laboratory (H) and (I). There can be doubts about reporting disease and these should be fully investigate, particularly where there is a commercial set up with independent veterinary staff. (F, G).

* Contingency plans. Vital as they prepare for all eventualities concernuing disease and responses. Action plan depend on measures outlined. Staff mobilization and protocols for control fully defined and practice needed.

** Action. This is the action taken on any scenario. Following reporting and confirmation of disease the exact sequence of events as defined in contingency plans is made. Communication then is vital both to the teams and laboratories involved as well as back from field via reporting and sampling requirements. The laboratory must be have enough planned reagents for most eventualities and thus this is a cost to be built into overall budgets. The ministry can then be activated to call for International help in the event of a major crisis (see arrows connecting M, J and N).

8.1. Methods exploited

D and E

Biosensors and pen side testing. Danger that mis-diagnosis (negative) is wrong. Samples must be taken and examined at better equipped laboratories. In remote areas can have higher value.



G

Possible laboratories enabling local testing for vaccine efficacy (e.g. ELISA) and PCR diagnosis. This has been set up in some commercial concerns. Reporting though not mandatory needs.Legislative clarity. Danger of miss-diagnosis and local measure inadequate to control disease.



H

Can be well equipped and would depend on size of a country and laboratories needed to cover geographical spread. Veterinarians could also be technicians here. ELISA suitable and good storage of samples for onward confirmation to central (regional labs). Molecular methods would depend on importance of lab. Staffing levels would have to be higher if PCR was run. Such laboratories also act as repositories fro sample collection equipment and reagents and possibly vaccines.



I

Top level laboratory able to do all techniques.

- Antigen isolation and identification through ELISA and PCR amplification, differential diagnosis. High capacity for outbreak situation, some automation where very extensive sampling needed. Involved in both routine confirmatory work and purposive sampling in control programmes, testing of vaccine efficacy, sero-monitoring, antigenic characterization at sequence level and molecular biological identification and molecular epidemiology.

- Research needs to can be met with staffing adequately trained.

- Reference center status also needed in regions to allow standards for conventional seologuy as well as PCR, EQA (also for conventional and PCR needs). May act as reference laboraroy in own right for a country or as central laboratory where country has several labs.

- Could get involved in ending kits for serology e.g. ELISA and for PCR (primers and protocols).

- Should be on accreditation pathway at least. (FAO and FAO/IAEA set up programmes for this and IAEA through TC projects.)

Figure 1.

South Asia - Priority Diseases

(Presented by V K Taneja, Deputy Director-General, ICAR (Animal Sciences), India)

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Summary recommendation of the Southeast Asia consultation on transboundary diseases

(Presented by Chaweewon Leowijuk, Deputy Director-General, DLD, Thailand)

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