Improving consumer Protection Against Zoonotic diseases Phase II

Improving consumer Protection Against Zoonotic diseases Phase II EuropeAid/133990/C/SER/AL The European Union s IPA 2012 programme for Albania Improving consumer Protection Against Zoonotic diseases Phase II Reference no. EUROPEAID/133990/C/SER/AL Interim report no. 3 Volume I 16 January 2014 to 15 July 2015 ii

Improving consumer Protection Against Zoonotic diseases Phase II EuropeAid/133990/C/SER/AL ii

Improving consumer Protection Against Zoonotic diseases Phase II EuropeAid/133990/C/SER/AL TABLE OF CONTENTS LIST OF ABBREVIATIONS... VI 1. INTRODUCTION... 8 2. EXECUTIVE SUMMARY AND RECOMMENDATIONS... 9 3. REVIEW OF PROGRESS AND PERFORMANCE TO DATE... 14 3.1 Policy and programme context 14 3.1.1 Policy and programme context... 14 3.1.2 Linkage to other ongoing operations... 14 3.2 Progress towards achieving objectives 15 3.2.1 Overall objective... 15 3.2.2 Project purpose... 15 3.2.3 Expected results... 15 3.3 Activities undertaken to achieve expected results 18 3.3.1 Result 1 Re-organization of the state veterinary service, staffed by appropriately trained, regulated and supervised veterinary professionals, which complies with international requirements is facilitated effectively.... 18 3.3.2 Result 2 - A coherent, integrated and fully operational animal disease surveillance system is in place.... 21 3.3.3 Result 3 Multi-annual, strategic programmes for the progressive control and eradication of priority animal diseases and major zoonoses are implemented effectively... 25 3.3.4 Result 4 Risk of human exposure to rabies from infected foxes in Albania is progressively reduced and eliminated... 31 3.3.5 Result 5 A sustainable, modern national communication system is established between the state veterinary service and key stakeholder groups 38 3.4 Resources and budget used 38 3.4.1 Personnel... 38 3.4.2 Equipment/Supplies... 39 3.4.3 Funding for incidental expenditure (operational costs)... 39 3.5 Assumptions and risks 41 3.5.1 Assumptions... 41 3.5.2 Risks... 41 3.6 Management and co-ordination arrangements 42 3.7 Financing arrangements 42 3.8 Key quality / Sustainability issues 43 iii

Improving consumer Protection Against Zoonotic diseases Phase II EuropeAid/133990/C/SER/AL 4. WORKPLAN FOR THE NEXT REPORTING PERIOD... 44 4.1 Results to be delivered quantity, quality and time 44 4.2 Activity schedule for the period to 15 January 2016 (revised with Addendum no. 3) 46 4.2.1 Re-organization of the state veterinary service (result 1)... 46 4.2.2 Animal disease surveillance system (result 2)... 47 4.2.3 Animal disease control (result 3)... 48 4.2.4 Oral rabies vaccination of foxes (result 4)... 49 4.2.5 National veterinary communication system (result 5)... 50 4.4 Updated risk management plan 55 4.5 Special activities to support sustainability 55 List of Tables Table 1: Reports of disease occurrence made through Forms A and B submitted to the RUDA/ADI system January to June 2015 24 Table 2: Number of animals vaccinated against anthrax 28 Table 3: Vaccine baits received in Albania for 2015 Spring ORV campaign 31 Table 4: Results of tests on batches of vaccine supplied for the campaign 32 Table 5: Overall distribution of vaccine baits 33 Table 6: Inputs by project experts (days) in the period January to June 2015 40 Table 7: Administrative Orders issued during the period 16 January to 15 July 2015 41 Table 8: Indicative work plan related to reform of the veterinary service to July 2015. 52 Table 9: Indicative work plan related to animal disease surveillance to July 2015. 52 Table 10: Indicative work plan related to animal disease control to July 2015. 53 Table 11: Indicative work plan related to oral rabies vaccination to July 2015. 53 Table 12: Indicative work plan related to veterinary communication to July 2015. 54 Table 13: Proposed inputs of experts in the period January to June 2015 54 List of figures Figure 1 Application of the OIE PVS Pathway scheme to track progress in veterinary reform in Albania... 19 Figure 2: Numbers of cases of anthrax reported annually 2006 to 2014... 27 iv

Improving consumer Protection Against Zoonotic diseases Phase II EuropeAid/133990/C/SER/AL List of Plates Plate 1 - The PAZA Media Liaison Expert addresses teachers at a meeting in the Ministry of Education and Sport, Tirana... 36 Plate 2 - A teacher explains the Oral Rabies Vaccination campaign to a class of pupils at a school in Pogradec... 36 Plate 3 The National Rabies Coordinator prepared a report on the 2014 Oral Rabies Vaccination campaign that was published in the hunters magazine Natyra... 36 Plate 4 - Positive case no. 2 Mediastinal lymph node of a bovine with generalized tuberculosis.. 37 Plate 5 Bovine tuberculosis - Positive case 2: Histopathological view: fibrotic granuloma, encapsulated caseous necrosis... 37 Plate 6 - Positive case no. 1 Mycobacterium bovis grown in Lowenstein-Jensen medium... 37 v

Improving consumer Protection Against Zoonotic diseases Phase II EuropeAid/133990/C/SER/AL LIST OF ABBREVIATIONS ADI Animal Disease Information AH Animal Health BIP Veterinary (or Phytosanitary) Border Inspection Post CVO Chief Veterinary Officer EC European Commission EU European Union FSVI/ISUV Food Safety and Veterinary Institute/ FVO Food and Veterinary Office of EC GIS Geographic Information System I&R Animal Identification and Farm Registration (EU-compliant) ISO International Organization for Standardization (in Geneva) IT Information Technology LogFrame Logical Framework (project planning methodology) MARDWA Ministry of Agriculture, Rural Development and Water Administration NVEU National Veterinary Epidemiology Unit NFA National Food Authority OIE Office International des Epizooties ORV Oral rabies vaccination (or vaccine) PCM Project Cycle Management (Guidelines) PSC Project Steering Committee QMS Quality Management System (in general: ISO 9001:2000) RUDA Database for the registration of identified animals (I&R system) SICCT Single intradermal comparative cervical tuberculin (test) ToR Terms of reference VPH Veterinary Public Health (consumer health protection) WHO World Health Organization vi

Improving consumer Protection Against Zoonotic diseases Phase II EuropeAid/133990/C/SER/AL vii

Improving consumer Protection Against Zoonotic diseases Albania EuropeAid/128304/C/SER/AL 1. INTRODUCTION Project name : Improving Consumer Protection Against Zoonotic Diseases Phase II Project location : Albania Duration : 47 months (adjusted) TA value : 2 324 000 Govt. contribution : 400 000 Total value : 2 724 000 Key stakeholders : The public in Albania; consumers of animal products, regulatory authorities, veterinary administration and services, livestock producers and traders in livestock and products of animal origin. Overall objective: Contribute to increased livestock health and productivity and improved protection of public health in Albania in line with the EU regulations for the control and monitoring of zoonotic agents. Project purpose: The capacity to plan, implement, monitor and sustain risk-based national strategies for the progressive control and eradication of target zoonotic diseases 1 is established. Key results (revised): Result 1: Re-organization of the state veterinary service, staffed by appropriately trained, regulated and supervised veterinary professionals, which complies with international requirements is facilitated effectively. [New result added as part of Addendum no. 3] Result 2: A coherent, integrated and fully operational animal disease surveillance system is in place. Result 3: Multi-annual, strategic programmes for the progressive control and eradication of priority animal diseases and major zoonoses are implemented effectively. Result 4: Risk of human exposure to rabies from infected foxes in Albania progressively reduced and eliminated. Result 5: A sustainable, modern national communication system is established between the state veterinary service and key stakeholder groups. Current project status: Implementation period third semester Author of the report: Robert Connor, Team Leader Including project component reports of: Toni Kirandjiski Ieva Rodze Ylli Pema Disease Surveillance Expert Laboratory Expert Raymond O Rourke Legislation Expert Institutional & Administrative Support Expert 1 Target diseases include brucellosis, anthrax, tuberculosis, CSF and rabies. 8

2. EXECUTIVE SUMMARY AND RECOMMENDATIONS On 23 April, the Project Steering Committee (PSC) met under the chairmanship of the General Secretary of the Ministry of Agriculture, Rural Development and Water Administration (MARDWA) to review the project s second interim report and the work plan for the period to mid- July 2015. In response to a request from the MARDWA, in April, the EU extended the scope of the project to include a new result (new expected result 1) Reform of veterinary service facilitated effectively : an additional 226 500 was allocated to the Consortium s contract to provide extended expert inputs and meet associated expenditure. There were few tangible outcomes from the Ministry s stated intention to merge the field veterinary service with the National Food Authority (NFA), which had been announced in November 2014. Consequently, the context of the project remained institutionally unsettled as the reporting lines of a reformed veterinary system were not decided; no new job roles or responsibilities were defined. In May, the project supported the Chief Veterinary Officer (CVO), the director general of the National Food Authority (NFA), the Dean of the Faculty of Veterinary Medicine, a member of the academic staff and two members of the project team to go to Dublin, Ireland, for a study visit. The UCD School of Veterinary Medicine hosted the visit, which paved the way for a twinning programme for the veterinary faculty and provided models for the integration of food safety and veterinary services. The project s Legislation Expert undertook two missions (April and June 2015) but staff changes in the veterinary directorate and the severe chronic shortage of personnel meant that no tangible progress was made between the expert s missions. The lack of sufficient full-time, qualified, English-speaking staff to the veterinary directorate impedes progress in Albania s compliance with international standards. An analysis of Albania s progress on the OIE PVS pathway scheme indicates clearly the main areas that have to be addressed. The continuation of this status would impede Albania s accession to EU membership. In July, the CVO presented the draft law on the Veterinary Order to the parliamentary commission on agriculture and the project team held follow up discussions to plan the establishment of a national veterinary register after the enactment of the new law. The project team continued to work with the CVO to plan project activities but since the restructuring of the veterinary service was not launched, no specific steps were taken to strengthen animal disease surveillance (expected result 2). The performance of the surveillance system was erratic during the first six months of the year: crucial shortcomings included the very low levels of disease reporting; the erratic use of animal identification in disease reporting; the low expectations of livestock owners of the veterinary service, and corresponding low levels of passive disease reporting; and, lack of application of performance indicators to drive the network. The Disease Surveillance Expert (DSE) reported that there is very little information on presence and distribution of diseases affecting animal population in Albania. He proposed surveillance activities for 2016, for which adequate budgetary provisions should be made. On the basis of the findings of this surveillance, appropriate prophylactic measures could be suggested. 9

The project s main disease control activities (expected result 3) included supporting the implementation of the annual vaccination of replacement small ruminants against brucellosis, which was largely completed by the end of June. The project team monitored the third oral rabies vaccination (ORV) campaign: distribution of the vaccine baits was completed on 21 May. The team actively supported the training and deployment of hunters throughout Albania; and, monitoring their performance. The diagnostic capacity of the ISUV s Animal Health Department continued to improve throughout the reporting period. During her fourth mission to Albania, in February, the Laboratory Expert commented favourably on the commitment of the staff of the animal health department to ensuring the accreditation of a range of diagnostic tests, linked to zoonotic diseases. In June, Laboratory Expert reported the proficient analysis of reference samples related to oral rabies vaccination (ORV) campaigns. She stated that regarding the diagnosis of brucellosis, it was not currently possible to carry out a full bacteria species and biovar determination due to the lack of specific reagents in the laboratory. The insufficient funding of the national reference laboratory (ISUV) prevented it from fulfilling its mandated role. This constraint is external to the project and should be resolve by the project s financing partners. The Laboratory Exert also provided guidance to the personnel of the Animal Health Department (AHD) and Director of ISUV on the biosafety requirements during the diagnosis of zoonoses, noting that these measures are not negotiable and require modest financial provision. The project supported training to address identified needs related only to the project s activities: this did not constitute a structured training programme, which continued to be of increasing concern because it is fundamental to improvement of the state veterinary service. In February, the Disease Surveillance Expert provided training to regional chief veterinary officers on the design of the bovine brucellosis control plan and the collection of samples, implementation of which was deferred until autumn. By June, the Laboratory Expert reported the significant progress that had been made as the bacteriologist gained essential skills related to the diagnosis of tuberculosis. In support of the rabies diagnostic tests, the project s Laboratory Expert provided coaching in techniques used to monitor the ORV campaigns, and provided materials to demonstrate the presence of tetracycline in foxes teeth. By the end of June, the basic tests to support ORV monitoring had all been established at ISUV s Animal Health Department. As in previous years, the regional veterinary service implemented the strategy to control anthrax: animals in listed villages were vaccinated with locally produced anthrax vaccine. The project team s understanding of the anthrax situation in Albania became progressively firmer and important conclusions and recommendations were made, as described in this report. However, detailed analysis of the epidemiology of anthrax in Albania cannot be made because of the lack of reliable data. The number of reported cases between 2006 and 2014 fluctuated with a peak of 40 cases in 2012. It was concluded that farmers in Albania are aware about the disease, but passive reporting is at a low level, and preventive vaccination (as implemented until 2012) was not evidence based. Samples submitted for laboratory confirmation were completely inappropriate and contraindicated on grounds of biosafety. The DSE provided a detailed analysis of prevailing practices related to anthrax control, which highlights important facts: control measures rely purely on vaccination of animals - as a result, animals and people within outbreak area are at continued risk because in many cases disposal of 10

carcasses was inappropriate; there is minimal cooperation with public health authorities at district level; vaccine production does not have compliant written procedures to guarantee the quality of the vaccine used; laboratory diagnosis was not performed in all suspect cases; diagnosis at regional laboratories was not sufficient to confirm the disease in line with OIE standards. However, diagnosis at ISUV was assessed now to be compliant with OIE standards. The amended strategy to control anthrax, recommended by the PAZA Project, introduced a risk-based approach, which the veterinary service had partially adopted. Implementation of this strategy started in 2013. Its main features require all reported suspect cases to be confirmed at the ISUV laboratory: these results can then be confidently regarded as confirmed outbreaks. Other significant aspects related to anthrax control are: 1. The improvement in the specimens sent for testing: in 2014, specimens consisted mainly of nasal swabs (usually accompanied by blood samples); blood samples alone; six were spleen samples. In previous years, pieces of spleen or ears were submitted for laboratory analysis, which is absolutely contraindicated on grounds of biosafety. 2. Labelling and traceability still has to be improved: the ear tag numbers of the animals sampled were recorded for only 7 of the 52 samples submitted in 2014. 3. Measures taken in suspected or confirmed cases of anthrax did not improve, i.e., the disease was not always confirmed and carcases were either incorrectly disposed of or not disposed of at all. This practice is completely unacceptable because it constitutes a major public health risk, as well as placing livestock at risk. 4. In 2013 and 2014, 18 outbreaks of anthrax were confirmed: 13 of these occurred in 12 villages in four districts. This indicates that the magnitude of the problem is not uniformly distributed in the country. Seven of 18 outbreaks (40%) occurred in villages with previous history of the disease. The project team made further recommendations to improve anthrax detection and control. The project again mobilized the 12 regional field coordinators to support the monitoring of the brucellosis vaccination of small ruminant replacement animals, which began in the Spring of 2015. A meeting was held on 3 July, when the coordinators reviewed the campaign. It was evident that the national approach to brucellosis control and the national awareness raising campaign had created a greater awareness among farmers of the disease and the importance of vaccination: they are beginning to demand vaccination for their animals. Several significant factors have improved the quality of the vaccination programme, including: the training provided for the private veterinarians, which minimized adverse effects of the vaccination; the improved effectiveness of the cold chain (supplied through the PAZA Project) had improved vaccine quality at the point of use; the coordination meetings with official veterinarians improved monitoring of the implementation of the campaign, although further improvements in coordination are required to achieve harmonized implementation. The DSE made recommendations to improve the quality of future brucellosis vaccination campaigns: the start of vaccination should be based on local (regional) conditions instead of adopting a rigid start date throughout the country; to reduce wastage, vials of only 25 doses should be purchased and, if feasible, a proportion of 10-dose vials should be supplied; the MARDWA audit team should be informed of the instructions provided to veterinarians to reduce 11

wastage and should conduct the audits accordingly; and, the system for transporting blood samples for post vaccination monitoring should continue, and be strengthened by the establishment of a formal, centrally managed contract between the beneficiary (represented by ISUV) and Posta Shqiptare. The results of post-vaccination serological monitoring were not available at the time of preparation of this report. The full monitoring report on the brucellosis vaccination campaign will be produced after the project team receives these data from the national brucellosis coordinator. Another major activity for the project was the provision of continued support for the vaccination of foxes to control rabies (expected result 4). The third oral rabies vaccination (ORV) campaign was completed on 21 May 2015 and a detailed report on the results of the project s monitoring activities was produced. The final report assessing the effectiveness of the 2015 Spring ORV campaign will be produced when laboratory results from the blood and brain specimens from foxes are available. It was concluded that, generally, vaccine distribution had been completed satisfactorily: distribution of baits over areas outside borders of Albania was minimal; there was improvement in limiting the distribution of vaccine baits over lakes compared to previous ORV campaigns. However, the distribution of vaccine baits over some urban areas has still to be improved. Whereas distribution of vaccine baits over lakes represents a loss of vaccine baits, their distribution over urban areas poses a risk to people, who might have contact with a potential hazard: ORV baits contain live virus vaccine. The density of distributed vaccine baits was satisfactory and it was concluded that foxes throughout Albania were more or less equally exposed to the vaccine baits. Nevertheless, the bait intake and the effectiveness of the vaccination campaign are influenced by other factors, such as competition for the baits, availability of other food sources, and health status of foxes. Results of laboratory tests on materials collected from shot foxes are awaited before conclusions can be made regarding the efficacy of the vaccination campaign. At the end of the reporting period, hunters had been mobilized throughout Albania to shoot 325 foxes, this number being derived from the internationally recommended sampling level of 4 foxes per 100 km 2 of treated area per annum. The project team made a series of recommendations to improve the implementation of future vaccination campaigns. The project again implemented public awareness campaigns linked to (a) the brucellosis vaccination campaign and (b) the ORV campaign (expected result 4). Multiple channels of communication were used to ensure the maximum level of awareness of each campaign. Six regional television channels and two national television stations were used and a media agency updated the TV Spots. Leaflets, posters, and labels were printed and again, schools were used as a channel through which information was disseminated. After a meeting was held in the Ministry of Education and Sport, to inform teachers of the third ORV campaign and ask for their cooperation, meetings were held in five schools to inform pupils and staff about rabies and the vaccination campaign. Local media were present at the meetings and video material was broadcast on regional television channels. Through the MARDWA, the Government of Albania s contribution met the operational costs of staff and their mobility but budgets were severely constrained; field staff mobility continued to be a matter of concern since it directly affects the reliability of disease surveillance. Inadequate budgetary provisions also led to the lack of essential consumables for laboratory diagnostic 12

work; shortages of other materials compromised the health and safety (biosafety) of laboratory workers. In the project s next reporting period, the samples will be collected to screen all larger herds in Albania for bovine brucellosis and measures will be implemented to initiate supervised, routine testing for bovine tuberculosis. In addition, the project will monitor the distribution of rabies vaccine baits during the fourth ORV campaign. Other activities will depend largely upon the action of the MARDWA regarding the reform of the veterinary service. In conclusion, overall, the project s external environment continued to pose serious risks that jeopardized its potential success despite the achievement of several important outputs. Unless the national food safety and veterinary system is reformed, project implementation will be incomplete. 13

3. REVIEW OF PROGRESS AND PERFORMANCE TO DATE 3.1 Policy and programme context 3.1.1 Policy and programme context Throughout this reporting period, the Ministry of Agriculture, Rural Development and Water Administration (MARDWA) was expected to undergo institutional reform, spearheaded by the restructuring of the state veterinary service. In response to a request from the MARDWA, the EU extended the scope of the project to include a new expected result (result 1) Reform of veterinary service facilitated effectively (Annex 1). An additional budget of 226 500 was made available through an addendum (Addendum no. 3) to the Consortium s contract to provide extended expert inputs and to meet additional incidental expenditure. The addendum was signed at the end of April 2015. The Ministry s policy to merge the field veterinary service with the National Food Authority (NFA) was announced in November 2014 and, accordingly, the project team continued its attempts to facilitate the process. However, few tangible outcomes were achieved (section 3.2.3) and, once more, the context of the project remained institutionally unsettled. The stated absence of an enabling legislative framework to support the future institutional arrangements represented a major impediment to decisions regarding the first steps to be taken in the reform. Because of these circumstances, the reporting lines in a reformed veterinary system were not decided; no new job roles or responsibilities were defined; and, despite the attendance of the project team in meetings in the Prime Minister s office to present and discuss reforms, by the end of the reporting period there was no concrete progress to report 2 in institutional terms. 3.1.2 Linkage to other ongoing operations The PAZA II Project continued its liaison with the National Food Authority regarding the possible merger of veterinary field services, food safety inspections related to products of animal origin, and veterinary diagnostics but, in the absence of firm decisions, the project was unable to link to other ongoing operations. There were no other projects with which the project could liaise regarding field level activities. However, the project team held further discussions with the team leader of the MARDWA IPA 2011 Support to Agriculture and Rural Development, IPARD like project ( 20.75 million) implemented by GIZ, and with the Director of the Payment Agency of the MARDWA to discuss possible incentives to improve the uptake of animal identification, on which the payment of some subsidies depends. The need for the Ministry to maintain an up to date farm register and to ensure correct, full identification of livestock continued to be a major concern for all parties: without a functional national system traceability of animals and products of animal origin could not be assured, which would have wide-ranging adverse consequences for the national food safety system. Exports of products of animal origin would also be severely limited. 2 On 16 July 2015, the first day of the next reporting period, a meeting was held in the office of the Minister of Agriculture, Rural Development and Water Administration. For the sake of coherent presentation of this report, the project s Note to the File regarding this meeting is appended (Appendix A). 14

3.2 Progress towards achieving objectives 3.2.1 Overall objective The project aims to Contribute to increased livestock health and productivity and improved protection of public health in Albania, in line with the EU regulations for the control and monitoring of zoonotic agents. To maximize its contribution to this goal, the PAZA II Project team liaised with other actors and projects in the sector (section 3.1.2). Although Addendum no. 3 extended the project s activities and duration, its overall objective did not change. 3.2.2 Project purpose The addendum did not change the project s purpose, which remained The capacity to plan, implement, monitor and sustain risk-based national strategies for the progressive control and eradication of target zoonotic diseases 3 is established. The negligible progress in the reform of the veterinary service (explained above and in Appendix A) jeopardized the project s success. 3.2.3 Expected results In line with Addendum no. 3, the extended project has five main components, namely: 1. Reform of the veterinary service; 2. Disease surveillance and monitoring; 3. Strategic disease control programmes; 4. Monitoring of oral rabies vaccination campaigns; and, 5. Establishing a modern veterinary communication system between the state veterinary service and the main stakeholder groups. The five results that the PAZA II Project is expected to achieve are reviewed briefly below; they are presented in the logical framework matrix (Annex 1). Result 1. Re-organization of the state veterinary service, staffed by appropriately trained, regulated and supervised veterinary professionals, which complies with international requirements is facilitated effectively. The Ministry s aim to merge the state veterinary service with the NFA (which had been announced in November 2014) gradually crystallized during this semester and by the end of the reporting period it was evident that this aim had become implicit policy. In February, the Team Leader prepared a draft of the main steps that would be necessary to unite the fragmented veterinary service: the regional veterinary service would be transferred to the NFA, as would the municipal veterinary service; the delivery of a range of veterinary services would be outsourced to private veterinary practitioners preferentially to those 3 Target diseases include brucellosis, anthrax, tuberculosis, CSF and rabies. 15

operating as veterinary stations; and, diagnostic and food safety laboratory facilities in Albania would function under the direct technical supervision of the Food Safety and Veterinary Institute. Other scenarios for the provision of laboratory services were under discussion but no documented proposal was available to the project. The Decision of the Council of Ministers (no. 230 of 20 March 2013) announced the functions and duties of local government veterinary services. The project team proposed that most of the duties could be transferred to authorized veterinarians working within veterinary stations, the establishment of which the Ministry intended to promote. In May, on behalf of the Minister of ARDWA, the Team Leader presented an outline of the reformed veterinary service to a meeting in the Prime Minister s office, focusing on the proposed establishment of veterinary stations and outsourcing of the delivery of veterinary services. Whilst the proposal was accepted, it was observed by several Ministers that the proposal was incomplete and did not represent the scope and scale of the reform that was anticipated. To assist the reform process, the project supported a study tour to the School of Veterinary Medicine in Dublin, Ireland, in which representatives from the Agricultural University of Tirana s School of Veterinary Medicine, the Veterinary Directorate, MARDWA, the National Food Authority and the project team participated (Annex 2). In June and July, the Team Leader and I&ASE spent a considerable amount of time following up discussions with key stakeholders, participating in consultations with key stakeholders but without tangible outputs. The Disease Surveillance Expert and Legislation Expert also assisted discussions of the reform process. Result 2. A coherent, integrated and fully operational animal disease surveillance system is in place. As previously reported, the project s activities had suffered a setback after the Chief Veterinary Officer (CVO) resigned in December 2014, and the project team continued to brief the acting CVO on the project s work plans, activities and progress. Since the restructuring of the veterinary service did not take place, no specific steps were taken to strengthen animal disease surveillance. However, the project team continued to support discussions with implementation partners on the requirements for disease surveillance. The arrangements for disease surveillance after the reform of the veterinary service were not clarified during these discussions, since in the absence of explicit policy - the different perspectives could not be reconciled. The performance of the surveillance system was erratic (section 3.3.2) and some districts made no reports of disease during the first six months of the year (Table 1). Result 3. Multi-annual, strategic programmes for the progressive control and eradication of priority animal diseases and major zoonoses are implemented effectively. In this reporting period, the project s main disease control activities consisted of supporting the implementation of the annual vaccination of replacement small ruminants against brucellosis, which was largely completed by the end of June (section 3.3.3); monitoring the third oral rabies vaccination (ORV) campaign. 16

Although distribution of the vaccine was completed on 21 May (result 4 below), the project team was active in supporting the training and deployment of hunters throughout Albania, and in monitoring their performance. As in previous years, the regional veterinary service implemented the strategy for the control of anthrax: animals in listed villages were vaccinated with locally produced anthrax vaccine. Data on the cases of anthrax diagnosed up to the end of June 2015 provided the basis for a comprehensive review of anthrax control in Albania (section 3.3.3; Annex 8.4). The diagnostic capacity of the ISUV s Animal Health Department continued to improve throughout the reporting period. In June, concerning the diagnosis of rabies, the project s laboratory expert observed: During this mission the sample panel of 10 positive and negative formulations prepared in Latvia National Rabies Reference Laboratory, Institute BIOR, were evaluated, assessing the confidence of experts. Expert, Liljana Lufo rated the samples with great care and in all cases the assessment was identical to the test results obtained in Latvia NRL for rabies. [Annex 7] However, regarding the diagnosis of brucellosis, the expert reported at this moment it is not possible to carry out a full bacteria species and biovar determination due to the lack of specific reagents in the laboratory. The insufficient funding of the national reference laboratory (ISUV) prevented it from fulfilling its mandated role: this constraint is external to the project and should be resolved by the project s financing partners. Result 4. Risk of human exposure to rabies from infected foxes in Albania progressively reduced and eliminated. Distribution of vaccine baits for the third ORV campaign was completed on 21 May 2015. As during the previous campaigns, the Disease Surveillance Expert (DSE) followed a detailed monitoring plan and, with the National Rabies Coordinator and project personnel, closely monitored the distribution of vaccine (Annexes 8.1 and 8.3). Subsequently, in close collaboration with the Ministry of Environment and the Federation of Hunters Associations of Albania, the project team again organized licensed hunters to shoot a sample of foxes in hunting areas during July, this time in all 36 districts. The aim was to provide a reliable estimate of the level of immunity against rabies achieved in the fox population. The scale of this activity necessitated the training of additional hunters, and renewal of the service agreement with the Posta Shqiptare for transportation of samples from all districts to the Animal Health Department laboratories at ISUV. The project s field coordinators were mobilized to liaise with and encourage the hunters to shoot the full quota of foxes, according to the monitoring plan. Their efforts supplemented those of the project s local Wildlife Expert, who liaised with the Forestry Department officials in each district urging them to facilitate the process according to the dispensation issued by the Ministry of Environment. 17

Result 5. A sustainable, modern national communication system is established between the state veterinary service and key stakeholder groups. The Communication Expert was not mobilized during this period and the project s local experts rolled out the project s awareness raising strategy to support the brucellosis vaccination campaign for remont small ruminants and the ORV campaign. Both campaigns were focused on maintaining a high level of public awareness of the two campaigns, each of which involved the use of live vaccines. In April, the project participated in a meeting at the Ministry of Education and Sport (Plate 1) and addressed teachers to explain the importance of informing schoolchildren (Plate 2) of the aims and risks of the ORV campaign. The Head of ISUV s Animal Health Department, who is also the National Rabies Coordinator, submitted a report on the 2014 ORV campaigns, which was published by the hunters federation in their periodical (Plate 3) to provide feedback to hunters who are important implementation partners for the project. Despite these prominent activities, in the absence of institutional certainty, no progress was made in establishing sustainable communication systems. 3.3 Activities undertaken to achieve expected results The project team discussed the project s work plan of activities during consultative meetings with the Chief Veterinary Officer (CVO), and senior veterinary staff. The following sections outline progress made in the implementation of the main activities that were included in the project s revised logical framework (Annex 1); these were monitored and a summary report was prepared (Annex 9). 3.3.1 Result 1 Re-organization of the state veterinary service, staffed by appropriately trained, regulated and supervised veterinary professionals, which complies with international requirements is facilitated effectively. 3.3.1.1 Assist the Ministry of Agriculture, Rural Development and Water Administration (MARDWA) to design and establish the appropriate institutional and administrative setup of the veterinary service in the frame of a broader administrative reform in the sector Broad, continuing discussions between the project team and the staff of the MARDWA confirmed the intention to merge the veterinary service and the National Food Authority. However, no written guidance was available of the precise reporting arrangements to support these changes, nor any indication of the timing of such changes. In the absence of a written policy or a plan, the project was unable to provide targeted technical support to develop an operational plan for measures to realize this intention (Appendix A). 18

Figure 1 Application of the OIE PVS Pathway scheme to track progress in veterinary reform in Albania 3. Veterinary Services Strategic Plan 4. Modernization of Legislation 5. Public/Private 1. PVS Evaluation 2. PVS Gap Analysis Partnerships 6. Country / Donor Projects 9. PVS Pathway Follow-up missions 7. Veterinary Education 8. Diagnostic Laboratories Explanatory notes: Pathway step Progress Status [RAG] 1. OIE PVS Evaluation reports two reports have been prepared 2008; 2014 2. Gap Analysis Done by veterinarians in Durres at a meeting in 2014 3. Veterinary Services Strategic Plan PAZA report available Reform of veterinary services PAZA Project is facilitating the development of strategies 4. Modernization of Legislation Law on Veterinary Order in progress All Veterinary Practitioners to be registered Code of Professional conduct to be published Law on Reform of Veterinary Services proposed 5. Public / Private Partnerships Private veterinary stations to provide official services 6. Country / Donor projects Reform of food safety & Veterinary MARDWA Sector Planning Document (2015) Other? 7. Veterinary Education Twinning Programme proposed with UCD, Ireland 8. Diagnostic Laboratories PAZA Project prepared a policy brief for veterinary laboratories 9. PVS Follow-up Mission Pending developments 19

To orient the project s approach to the veterinary reform, the project team referred to the guidelines of the World Animal Health Organisation (OIE) PVS Pathway (Fig. 1). At a glance, it is apparent that the lack of a veterinary strategy and the lack of a policy on diagnostic laboratories limit progress in the modernization of Albania s veterinary service. 3.3.1.2: Advise and assist the MARDWA to revise and propose the necessary changes in the main veterinary legislation The project s Legislation Expert undertook two missions (Annexes 3 and 4). He reviewed the status of the draft law on the veterinary order and examined implications of changes that would be required to align existing legislation, first, with EU legislative framework and, second, to harmonize national legislation related to Food Law, Veterinary Law, Local Government Law, and the Inspection Law. During his mission in June, the Legislation Expert was not able to meet the MARDWA s director of Legal Affairs before leaving Tirana at the end of his mission. Consequently, without crucial guidance on procedures that should be followed in the elaboration of new legislation in Albania, the project s contributions to the amendment of key legislation were limited. 3.3.1.3: Following a functional review, advise the MARDWA on the most appropriate structure of the veterinary service including functions, number and qualification of staff, tasks and responsibilities, and communication The project prepared a proposal for the Minister and discussed options for the reform of the veterinary service. Thereafter, the sole focus of discussions was on veterinary stations, the establishment of which did not progress during this reporting period to a point where numbers of staff were considered. In discussions with the Director General of Agricultural Services and officers of the veterinary directorate, the project team highlighted the possibility that a large number of relatively older (>55 years) veterinarians might be involved in the restructuring exercise. Arrangements would have to be made to manage this scenario. The team pointed out the opportunity that reform would present to downsize and streamline the establishment possibly through a voluntary redundancy scheme this initiative could be linked to the outsourcing of official services to those new veterinary stations that would be authorized to deliver official controls and specified services. Subsequently, younger, computer literate, Englishspeaking staff could be engaged to support the reformed veterinary structures. However, there was no comment on these suggestions. 3.3.1.4: Provide advice on the upgrading of the implementing legal framework, including the revision of contracts for authorized veterinarians, veterinary order, veterinary stations etc By April, with contributions from the Legislation Expert and the Disease Surveillance Expert, a new model contract for veterinary stations had been drafted, 20

which took into account lessons learned from the delivery of private veterinary services in Macedonia. The project team provided the model contract to the CVO. In the absence of clarity regarding the structure of the reformed veterinary service and lines of reporting and supervision, it was not possible to prepare contracts for other service providers (authorized veterinarians). On 15 July (the last day of this semester), the CVO presented the draft law on the veterinary order to the parliamentary agricultural commission. It might be possible to report further progress in the next reporting period. 3.3.1.5: Assist and support the veterinary service to set up the capacities for the transposition of the acquis and its updating The Legislation Expert reviewed a list of EU legislation with which Albanian veterinary legislation should be aligned. However, in view of staff changes in the veterinary directorate and a severe chronic shortage of personnel, progress was not made in the period between the expert s two missions (April and June 2015). The Government of Albania should be encouraged to recognize that unless the Ministry appoints more full-time, qualified, English-speaking staff to the veterinary directorate, it will not be possible to implement this activity fully nor for Albania to comply with international standards. The continuation of this status would impede Albania s accession to EU membership. 3.3.1.6 Complete training needs assessments for each element of the reformed veterinary service structure and establish a progressive, sustainable training programme. The project facilitated a study visit to Ireland (Annex 2) to discuss options for a twinning programme between the veterinary schools in Dublin and Tirana, and to assess options relevant to Albania for the reorganization of the food safety and veterinary system. In the absence of a reformed structure, no systematic needs assessment could be completed. After 18 months of project implementation, the consortium s Human Resource Development (HRD) expert had still not been mobilized. 3.3.2 Result 2 - A coherent, integrated and fully operational animal disease surveillance system is in place. The project team continued dialogue with the new, acting CVO and had discussions with individual members of the task group that was formed in December 2014 to continue to coordinate the reform of the veterinary service. Animal disease surveillance will remain an essential major component of the reformed veterinary system, which would integrate the functions hitherto assigned to local government departments. However, as stated above, and explained in Appendix A, at the end of the reporting period, the process of planning the reform had not progressed pending the arrival in their posts of the newly appointed mayors of the 61 local administrations formed after the June 2015 local elections. Prior to the reform of local government, there had been more than 300 municipalities. 21

3.3.2.1 Review, in close cooperation with the Animal Health Sector in the Ministry of Agriculture, the list of the priority animal diseases subject to surveillance in Albania. The outbreak of blue tongue virus (BTV) infections in 2014 represented a new threat to animal health in Albania and it had the effect of activating the disease surveillance network. However, during this reporting period, the review of priority diseases did not take place since the understaffed veterinary directorate experienced further staff changes, which severely depleted institutional knowledge, and interrupted the project s conversation with key actors. Restarting discussions was impeded by the limited availability of the new staff who were, understandably, engaged in adjusting to their new roles and clearing backlogs of work. 3.3.2.2 Develop a framework of implementing legislation under the Law on the Veterinary Service. As already explained, the project s Veterinary Legislation Expert visited Tirana in April and June (Annexes 3 and 4) to review the progress made by the Albanian authorities in drafting veterinary legislation, assist in drafting a contract for veterinary stations, and map the scope of the veterinary legislation that would have to be addressed to support a restructured, combined food safety and veterinary system. The CVO presented the draft law on the Veterinary Order for the establishment of an Albanian veterinary statutory body to the parliamentary agricultural commission on 15 July. Since the roles of the Ministry of Agriculture and the National Food Authority, in relation to competences and the enforcement of legislation in the veterinary field, had not been explicitly clarified during this reporting period, the project team could not make further suggestions about the legislative framework needed to support a reformed, combined food safety and veterinary system. Once again it has to be reported that the protracted discussions on restructuring the veterinary service had produced no final output: the institutional context of the project thus continued to be unsettled and uncertain. 3.3.2.3 Establish functional tools enabling disease notification information and epidemiological data to flow through a national surveillance network. It was previously reported that the prime prerequisite for the implementation of this activity is the existence of a national surveillance network: but this was not fully functional during this semester. Crucial shortcomings included: the very low levels of disease reporting from several districts (Table 1); the erratic use of animal identification in disease reporting (section 3.3.3.4, point 11, and Annex 8.4); the low expectations of livestock owners of the veterinary service, and corresponding low levels of passive disease reporting; lack of engagement by public health services in a one-health approach to the surveillance of zoonoses (Annex 5); and, lack of application of performance indicators to drive the network. In the report on her fifth mission to Tirana (Annex 7), the project s Laboratory Expert emphasized the need for a laboratory information management system (LIMS) to be established, noting that it appeared not to be a priority. The DSE also highlighted the importance of a LIMS (section 3.3.3.4, recommendation vii). 22

3.3.2.4 Support the establishment of an effective and credible laboratory service in line with OIE (ISO 17025) standards. During her fourth mission to Albania, in February, the Laboratory Expert commented favourably on the commitment of the staff of the animal health department to ensuring the accreditation of a range of diagnostic tests, linked to zoonotic diseases (Annex 6). These included: 1. RBT for brucellosis antibody detection in serum 2. SAT for brucellosis antibody detection in serum 3. ELISA test for brucellosis antibody detection in serum 4. CFT for brucellosis antibody detection in serum 5. FAT for rabies antigen detection in brain tissue 6. Rabies virus isolation in cell culture and identification by FAT The Laboratory Exert also provided guidance to the personnel of the Animal Health Department (AHD) and Director of ISUV on the biosafety requirements during the diagnosis of zoonoses. The personal protective equipment must include: 1. disposable laboratory smocks and overalls 2. disposable caps and boot swabs 3. disposable aprons and sleeves 4. disposable respirators 5. visors She noted that these measures do not require a large financial investment but that they are prerequisites for biosafety. 3.3.2.5 Complete training needs assessments for each element of the surveillance network and establish a progressive, sustainable training programme. Without a defined surveillance network as explained above implementation of this activity could not be addressed in a systematic manner. Nevertheless, the project supported training to address identified needs. In February, the Disease Surveillance Expert provided training to regional chief veterinary officers on the design of the bovine brucellosis control plan and the collection of samples (Annex 5). In the same month, the Laboratory Expert identified the need for the bacteriologist to receive training in the methods to be used to isolate and identify tubercle bacilli in the diagnosis of bovine tuberculosis. By June, the Laboratory Expert reported the significant progress that had been made as the bacteriologist gained essential skills related to the diagnosis of tuberculosis (Annex 7). Gross pathology (Plate 4) had led to a presumptive diagnosis of tuberculosis in a positive reactor cow; histopathology had confirmed the typical fibrotic granulomatous lesion (Plate 5) but contamination of the bacteriological culture (Plate 6) necessitated retesting and conclusive results were not available at the time of writing this report. In support of the rabies diagnostic tests, the project s Laboratory Expert also provided coaching in the range of techniques to be used to monitor the ORV campaigns, and provided materials to demonstrate the presence of tetracycline in foxes teeth. By the end of June, the basic tests to support ORV monitoring had all been established at ISUV s Animal Health Department. 23

The summary of disease reports, prepared by the NVEU (Table 1), was an important product. As well as indicating the level of surveillance, it also highlighted which veterinary offices had been inactive in disease reporting in the first six months of the year. Table 1: Reports of disease occurrence made through Forms A and B submitted to the RUDA/ADI system January to June 2015 DISTRICT January February March April May June Total BERAT 0 0 0 2 9 3 14 BULQIZE 1 1 1 0 4 4 11 DELVINE 0 0 1 0 2 2 5 DEVOLL 0 0 0 1 3 3 7 DIBER 4 3 0 4 0 1 12 DURRES 1 5 5 0 2 2 15 ELBASAN 0 0 0 0 0 0 0 FIER 0 20 21 22 16 26 105 GJIROKASTER 0 0 1 2 2 3 8 GRAMSH 6 12 15 12 26 22 93 HAS 0 0 0 0 0 0 0 KAVAJE 0 5 0 0 0 0 5 KOLONJE 0 0 0 0 2 7 9 KORCE 0 1 2 7 14 12 36 KRUJE 0 0 0 0 10 0 10 KUCOVE 0 0 0 2 3 7 12 KUKES 2 3 4 4 3 0 16 KURBIN 2 0 1 0 0 2 5 LEZHE 0 0 0 0 0 0 0 LIBRAZHD 18 23 24 27 12 14 118 LUSHNJE 10 6 3 2 7 4 32 MALESI E MADHE 2 1 1 1 8 6 19 MALLAKASTER 9 11 11 9 9 11 60 MAT 4 4 7 3 2 2 22 MIRDITE 0 0 10 5 0 0 15 PEQIN 1 12 0 0 0 0 13 PERMET 0 0 0 0 6 3 9 POGRADEC 1 1 1 16 0 10 29 PUKE 10 18 14 0 12 6 60 SARANDE 0 0 1 0 1 3 5 SHKODER 5 18 7 6 7 11 54 SKRAPAR 0 0 0 0 0 2 2 TEPELENE 0 1 2 0 0 3 6 TIRANE 11 18 12 5 1 1 48 TROPOJE 0 0 0 0 1 4 5 VLORE 15 30 2 7 4 1 59 TOTAL 102 193 146 137 166 175 919 The expected output of the surveillance system related to data on the vaccination of small ruminants against brucellosis had not materialized at the time of writing this report (Annex 8). The DSE reported 24

There is very little information on presence and distribution of animal diseases that are affecting animal population in Albania. Reasons for this deficiency are numerous, including continuous lack of appropriate budget to finance such activities. Collection of samples presents the most expensive and difficult aspect of active surveillance. Submitted proposal for active collection of epidemiological data and diagnostic testing of collected specimens from animals are mainly connected with activities which - with support of the PAZA project - are already established and are being implemented in Albania. Established active surveillance will result in foundation of an early warning system for many diseases that are currently considered to pose risk for domestic livestock population in Albania. Moreover, foreseen diagnostic testing will shed light on the real situation in regards to the risk, presence and distribution of different animal diseases, including diseases with zoonotic potential. [DSE report; Annex 8] Training alone will not rectify the numerous constraints that confront the animal disease surveillance network. 3.3.3 Result 3 Multi-annual, strategic programmes for the progressive control and eradication of priority animal diseases and major zoonoses are implemented effectively 3.3.3.1 Prepare the list of animal diseases to be addressed by official prophylactic measures. For the reasons already mentioned (section 3.3.2.1), during this reporting period, the project team did not progress with the revision of the list of diseases to be addressed by official prophylactic measures. The recently arrived CVO, the under-staffed veterinary directorate and newly assigned personnel had insufficient capacity to address their own work during their settling in period let alone attend to the project s demands on their time. Consequently, as before, the project team focused its activities on: a) the oral vaccination of foxes (expected result 4); b) supporting the monitoring of brucellosis vaccination of small ruminant replacement animals in the Spring of 2015; c) preparing for the continued investigation of the aetiology of bovine brucellosis in Albania; d) monitoring the implementation of the anthrax control strategy proposed by the PAZA Project, which hinges on timely diagnosis of the disease in reported cases; and, e) the completion of a pilot study of bovine tuberculosis, based on tracing back from cases detected at slaughter (reported above). 25

3.3.3.2 Establish multi-annual eradication programmes for each animal disease subject to official prophylactic measures. During this reporting period, the veterinary directorate followed the plans that had been developed in 2013 and for which funding had been allocated for use in 2015. The predominant programmes were the control of brucellosis in small ruminant replacement animals, and the vaccination against anthrax of animals in listed villages at risk. In addition, the project continued to monitor the EU-funded oral rabies vaccination (ORV) programme to control rabies in the red fox population. Preparatory discussions took place regarding the screening of large herds of cattle for the presence of brucellosis. Testing is expected to proceed in the last quarter of 2015. The Disease Surveillance Expert proposed surveillance activities for 2016, when budgetary provisions should be made. On the basis of the findings of this surveillance, appropriate prophylactic measures could be suggested. 3.3.3.3 Prepare operational plans for the delivery of eradication programmes and provide necessary training (initial and refresher) to relevant staff. As previously explained, the overriding need was for the establishment of the veterinary organizational structure as a prerequisite for the development of strategies for the control of priority diseases. However, this precondition remained unfulfilled. In February, the DSE participated in a two-day workshop with representatives from the veterinary directorate, regional chief veterinary officers, staff of the Animal Health Department of ISUV, and the project s field coordinators. Based on experience gained from previous campaigns, steps and actions for strengthening of the implementation of the vaccination campaign were presented. These included the clear division of responsibilities of all stakeholders (private veterinarians, official veterinarians, regional CVOs, NVEU and ISUV, SVS and PAZA II project). Operational plans were agreed for the vaccination of replacement sheep and goats against brucellosis, and the plan for the control of bovine brucellosis was adjusted. The bovine brucellosis control plan (BBCP) was discussed in details and its time frame for implementation agreed. The start of field implementation of milk sampling was agreed for June 2015 to avoid overlapping with implementation of the vaccination campaign in sheep and goats. However, due to under-capacity in the veterinary directorate and the local elections that were held on 21 June, the implementation of the programme was deferred to the last quarter of the year. 3.3.3.4 Provide regular reports on progress within each eradication programme and the costs incurred in its delivery. The DSE again reviewed the data available on the anthrax situation and produced a detailed report (Annex 8.4). The project team s understanding of the anthrax situation in Albania has become progressively firmer and important conclusions and recommendations can be made, as explained below. 26

The main preventive control measure is vaccination of animals within villages that have a history of anthrax: the disease has usually been confirmed at regional laboratory, at ISUV, or more frequently simply on clinical grounds, including the presumed risk arising from a village s proximity to an outbreak in a neighbouring area. In line with the strategy proposed by the PAZA Project in 2010, the number of vaccinated animals should decline as villages that have not had anthrax outbreaks in the previous 10 years are removed from the list of villages where vaccination is to be performed. For example, based on an analysis of outbreaks in 2014, 34 villages should have been excluded from the list of to be covered by the 2015 campaign. Although the number of animals vaccinated in recent years has declined, there was no consequent increase in the number of reported cases of anthrax, with the possible exception of 2012. Spatial and temporal data from the regional laboratories before 2012 was heavily influenced by two factors: - Data were collected in situations where accurate reporting was not enforced, probably decreasing the number of reported cases; and, - Recorded suspect cases were not always confirmed by reliable laboratory tests. The absence of differential diagnosis and final confirmation of the disease probably increases the apparent number of cases. Therefore, taking these factors into account, detailed analysis of the epidemiological situation on the basis of these factors was not justified and reliable epidemiological inferences cannot be drawn. The number of reported cases between 2006 and 2014 fluctuated from a peak of 40 cases in 2012 to 7 cases in 2013 (Fig. 2). Figure 2: Numbers of cases of anthrax reported annually 2006 to 2014 Source: WAHID OIE for 2006 2012 and AHD ISUV for 2013 and 2014 The main conclusions on the anthrax situation until 2012 can be summarized as: 1. Passive reporting. Farmers in Albania are aware about the disease, however, the number of passively reported suspect cases is probably underestimated in conditions when unified response from the SVS is not enforced. 2. Preventive vaccination as implemented until 2012 was not evidence based. Animals from many villages remain to be at risk since there were no reported 27

cases. At the same time, animals in many villages were preventively vaccinated only based on clinical suspicion or preliminary diagnosis of the disease and without sustained risk analysis. 3. Submitted samples for laboratory confirmation were completely inappropriate and contraindicated on grounds of biosafety. Table 2: Number of animals vaccinated against anthrax Year Number of listed villages Sheep and goats Cattle Pigs Equines Financial resources (ALL) 2010* NA 854.000 150.000 NA NA 33.120.000 2011* NA 902.200 134.000 NA NA 33.766.000 2012* NA 600.000 100.000 NA NA 23.000.000 2013* 248 500.600 79.600 NA NA 18.998.000 2014* NA 424.455 60.935 NA NA NA 2014** 161 376.611 37.786 10.888 9.652 NA 2015*** 171 363.625 29.359 9.268 6.937 NA Legend: NA Not available * Data according to SVS ** Data according to NVEU *** Foreseen, excluding 34 villages that should be removed from the list Source: NVEU and SVS 4. Control measures were targeted only to vaccination of animals. No further control measures were implemented especially aiming to reduce the number of bacterial spores in the environment. As a result, animals and people within outbreak area are at continued risk and further outbreaks may occur in cases when animals are not vaccinated or the vaccination did not produce immunity (for any reason), even if several years passed since the last outbreak. 5. In many cases disposal of carcasses was done inappropriately and in fact only perpetuate the risk. 6. Cooperation with public health authorities on district level is established but there is no written common approach in case of outbreaks. 7. Vaccine production does not have written procedures to guarantee the quality of the vaccine used. 8. Laboratory diagnosis was not performed in all suspect cases. Diagnosis at regional laboratories was not sufficient to confirm the disease in line with OIE standards. Diagnosis at ISUV was assessed as compliant with OIE standards. 28

In 2012, the PAZA project proposed an amended strategy for the control of anthrax. The strategy introduced a risk-based approach, which was partially adopted by the SVS. The implementation started in 2013. The main outcomes of the adopted strategy are: 9. All reported suspect cases were laboratory confirmed at ISUV. Therefore, the confirmed laboratory results can be confidently regarded as confirmed outbreaks. 10. In 2014, specimens consisted mainly of nasal swabs (usually accompanied by blood samples); blood samples alone; six were spleen samples. This can be regarded as a great improvement compared to the previous period when pieces of spleen or ears were submitted for laboratory analysis, which is absolutely contraindicated on grounds of biosafety. Specimens for laboratory confirmation were triple packed and transported by the Albanian Post Office courier service, which was very efficient. 11. Much improvement remained to be done in regards to the labelling and traceability: the ear tag numbers of the animals sampled were recorded for only 7 of the 52 samples submitted in 2014, meaning that traceability was not generally achieved. 12. Measures that have been implemented in case of suspicion and confirmation of the disease, including the disposal of carcases, did not differ from the previous years and was assessed to be insufficient. 13. In 2013 and 2014, 18 outbreaks of anthrax were confirmed: 13 of these occurred in 12 villages in four districts. This indicates that the magnitude of the problem is not uniformly distributed in the country. Seven of 18 outbreaks (40%) occurred in villages with previous history of the disease. The main recommendations may be summarized as: i. Preventive vaccination against anthrax should continue to be risk based. The list of villages needs to be updated annually. ii. Final laboratory confirmation of the disease should be conducted at AHD ISUV. iii. iv. Much improvement is required in implementation of additional control measures in case of suspicion or confirmation of the outbreak. The specimen submission system needs to be sustained. v. Inconsistent data was received from the two sources consulted: NVEU (RUDA) and SVS (data collected for the payment of activities) indicating the existence of parallel systems for collection of data. vi. vii. Absence of appropriate I&R system precludes traceability. As a priority, the AHD-ISUV should be linked to the animal health information system by the development of LIMS module to integrate it with the RUDA system. A monitoring report on the brucellosis vaccination campaign will be produced after the project team receives data on post-vaccination monitoring from the national brucellosis coordinator. The project monitored the implementation of the campaign 29

through the 12 regional field coordinators, who attended a review meeting at the PAZA Project office on 3 July (Annex 8.5). After well-informed, structured discussion, it was concluded that through the adoption of a national approach to brucellosis control and a national awareness raising campaign, farmers generally know about the disease and the importance of vaccination. They are beginning to demand vaccination for their animals. Several significant factors have improved the quality of the vaccination programme, including: The training provided for the private veterinarians, which minimized adverse effects of the vaccination with a live vaccine The establishment of an effective cold chain by the PAZA Project has improved vaccine quality at the point of use The coordination meetings with official veterinarians improved monitoring of the implementation of the campaign, although further improvements in coordination are required to achieve harmonized implementation. A vaccination campaign is often considered to be the simplest and easiest control method to implement, however, several problems were encountered because not all preconditions were fulfilled. The gaps included: - Incomplete identification and registration of animals - Weak coordination of activities in the field, and - Erratic monitoring of vaccination by the official veterinarians The DSE made several recommendations to improve the quality of future vaccination campaigns. Vaccination should start in a region depending on local conditions, i.e., instead of a rigid start date throughout the country, implementation should accommodate variations in breeding patterns and animal movements, to achieve best result. Since it is intended to vaccinate only replacement animals in the coming years, it is recommended that, vials of only 25 doses should be purchased or, if technically and economically feasible, a proportion of 10-dose vials should be supplied. This would reduce wastage and encourage field veterinarians to vaccinate replacement animals in very small flocks/herds. The MARDWA should advise contracted veterinarians of the procedures they should follow to account for unavoidable wastage of vaccine. The MARDWA audit team should also be informed of these instructions and should conduct the audits accordingly. The system for transporting blood samples for post vaccination monitoring should continue, and be strengthened by the establishment of a formal, centrally managed contract between the beneficiary (represented by ISUV) and Posta Shqiptare. The results of post-vaccination serological monitoring were not available at the time of preparation of this report. 30

The third oral rabies vaccination (ORV) campaign was completed on 21 May 2015 (see 3.3.4 below) and a report on the quality of the ORV distribution was produced (Annex 8.3). The final report assessing the effectiveness of the 2015 Spring ORV campaign will be produced when laboratory results from the blood and brain specimens from foxes have been tested. The DSE prepared the final report of post vaccination monitoring in 2014 (Annex 8.2). 3.3.4 Result 4 Risk of human exposure to rabies from infected foxes in Albania is progressively reduced and eliminated 3.3.4.1 Assess the arrangements made by the vaccine supplier to handle, store, transport and distribute the vaccine baits. The project liaised closely with the local representative of the EU s Contractor for the supply of the rabies vaccine and monitored the organization of vaccine delivery, storage and distribution (Annexes 8 and 8.1). The project team and the National Rabies Coordinator again liaised with the Albanian authorities, i.e., veterinary service, Institute of Public Health, Civil Aviation Authority for approval of flights, Ministry of Defence who granted use of the military airfield at Kucovë during the vaccine distribution, and Ministry of Environment regarding permits to shoot foxes. Before the campaign, the project submitted to the Project Manager and CVO, a report on the Contractor s preparedness, the status of infrastructure, the procedures to be followed including tests results, based on which the ORV campaign was started. The project s staff that monitored implementation of the campaign included the DSE, I&ASE, Field Monitor, and the local GIS Expert. 3.3.4.2 Monitor the quality of the baits supplied during each vaccination campaign. The project worked closely with the National Rabies Coordinator and the DSE used standard procedures to check the quality of the baits supplied. A total of 560 000 baits were received in three batches (Table 3). Table 3: Vaccine baits received in Albania for 2015 Spring ORV campaign Batch number Number of baits Expiry date 9371214-B 57.600 18.12.2016 9381214-A 262.400 20.12.2016 9401214-A 240.000 27.12.2016 Total 560.000 31

Table 4: Results of tests on batches of vaccine supplied for the campaign Since the laboratory testing performed at PEI only partially fulfilled the requirements stated in the Article 25 of the Special Conditions of the contract, the samples were sent to the OIE Reference Laboratory at the Friedrich-Loeffler Institute (FLI) in Germany where required laboratory tests were performed. Samples were collected on the last day of the autumn ORV. The repeated laboratory tests produced satisfactory results (Annex 6 of Annex 8): the results of the vaccine virus titre and vaccine virus stability after exposure for 7 days on 25 C were in compliance with the vaccine specifications. The bait casing remained intact under all conditions tested. At 40 C the consistency of the bait casing became sticky and soft but still remained intact. Therefore, the melting point of the bait casing above 40 C complied with EU recommendations. To ensure constant supervision of the field operations, the project s field-based monitor conducted daily checks on the conditions of the storage of the imported vaccine baits and monitored compliance with prescribed procedures in the cold store and airfields: he despatched daily records to the project office. The project collected and submitted all documentary evidence (data logger reports) regarding the cold chain during the whole process (from vaccine manufacture until the day of the distribution of baits), and monitored the cold chain throughout from the delivery in the central cold store until the loading into the aircraft. All data were placed in an ORV dossier that was kept at the project office. 3.3.4.3 Monitor the performance of the vaccine supplier during each vaccination campaign. As in previous campaigns, the project team maintained daily contact with the local representative of the vaccine supplier during the vaccination campaign and reviewed activities and progress. The contractor had acted on the recommendation to amend the flight routes to avoid distribution of vaccine baits over urban areas and new flight routes were submitted. The project s full-time field-based monitor performed checks at the airfield and senior project staff made unannounced spot checks when vaccine distribution was in progress. The Consortium mobilized the project s GIS expert, who analysed data on a daily basis during the campaign. 32

The terms of reference of the ORV programme state that vaccine baits should not be distributed in urban areas, water bodies or at altitudes above 2 000 metres. However, analysis of data from the 2014 autumn ORV campaign indicated that the topography of the Albanian highlands affected the quality of distribution in the surrounding areas; in addition, hunters suggested that foxes are also found at higher altitudes. Thus, it was recommended that, henceforth, high altitudes should be included in the target area. A shape file was created, which included only so called non-target areas. Although for lakes and borders of Albania the shape files were correct and precise, in the 2014 ORV campaigns, a precise shape file indicating urban areas was not readily available. Therefore, for this analysis, a new shape file was prepared manually: based on the projections, urban areas were identified, selected and included in the non target area shape file. Based on this shape file, the contractor prepared a new distribution plan with the projected flight lines. The results of the campaign (Table 5) were evaluated against these revised criteria. Table 5: Overall distribution of vaccine baits Analysis of data on the distribution of vaccine baits over urban areas showed: 1) Several instances were noted where vaccine baits were distributed over bigger urban areas: Tirana, Elbasan and Librazhd (Annex 8.3 - Images 1 a), b) and c)). 2) A Public Health Institute representative reported that several contacts with a vaccine baits had occurred, one of which was near the beach of Qerret. Analysis of the data showed that there were only four baits near the village and the beach of Qerret (Annex 8.3 - Image 1 d)). 3) Hunters reported presence of vaccine baits in the city of Korca. Analysis of data revealed that no vaccine baits had been distributed over the city of Korca but in the outskirts of the city, which is within the target areas (Annex 8.3 - Image 1 e)). 4) Distribution of vaccine baits unavoidably occurred over many smaller urban areas. It was concluded that 1) Distribution of baits over areas outside borders of Albania was minimal. 2) The distribution of vaccine baits over lakes was more limited than in previous ORV campaigns. The number of baits distributed over lakes decreased from 8 953 and 5 427 in 2014 Spring ORV, 2014 Autumn ORV, respectively, to 2 290 in the 2015 Spring ORV (Table 8). 33

3) Distribution of vaccine baits over urban areas has still to be improved. Whereas distribution of vaccine baits over lakes may be regarded as a loss of vaccine baits, the distribution of vaccine baits over urban areas should be regarded as posing a risk of human contact with a potential hazard, since the ORV baits contain a live virus vaccine. In addition, the density of distributed vaccine baits was considered to have been very good. It was, therefore, concluded that foxes throughout Albania were more or less equally exposed to the vaccine baits. Nevertheless, the bait intake and the effectiveness of the vaccination campaign is also influenced by other factors such as competition for the baits, availability of other food sources, health status of foxes. Consequently, the project team recommended that: 1) Further improvement of the flight lines plan is required to avoid distribution of vaccine baits over urban areas. 2) The contractor should prepare and implement a training programme for the personnel responsible for the distribution of the vaccine baits. The training programme should address all shortcomings identified during the previous ORV campaigns. 3) Evidence of the effectiveness of the training programme should be submitted to the Programme Manager prior to the next ORV campaign. 4) The contractor should present a report on the remedial actions taken, at a meeting before the start of the next ORV campaign. 5) The project team recommended a meeting with representatives of neighboring countries which also implement ORVs to coordinate distribution of vaccine baits in border areas to achieve better coverage across borders. 3.3.4.4 Prior to each vaccination campaign, deliver public awareness information and provide guidance to health authorities and local government services; In line with the plan developed by the project s Communication Expert, local experts and counterpart staff implemented the project s communication strategy. The integrated actions to support the previous national oral rabies vaccination (ORV) campaign were repeated during the third campaign in May 2015. The project strategy again used multiple channels of communication to ensure the maximum level of awareness of the ORV campaign. The project used six regional television channels (Elbasan, Lushnje, Gjirokaster, Vlore, Kukes and Berat) and two national television stations RTSH and ABC News. A media agency updated the TV Spot, and a printing house printed 25 860 leaflets, 30,105 posters, 2 700 sender/receiver label stickers and 2 700 envelopes to distribute materials to schools to raise awareness against rabies. In April, a meeting was held in the Ministry of Education and Sport to inform teachers of the third ORV campaign and ask for their cooperation (Plate 1) in distributing the awareness raising materials and informing schoolchildren of about rabies and its control. Subsequently, meetings were held in five schools (Permet, Gjirokaster, Kukes, Pogradec, Fier) to inform pupils and 34

staff about rabies and the vaccination campaign (Plate 2). Local media were present at the meetings and video material was broadcast on regional television channels. The project s www.lufto-terbimin.al was updated and linked to a facebook account. 3.3.4.5 Support the continued development of rabies diagnostics at ISUV. By December 2014, most of the essential materials for rabies diagnostics had been delivered to ISUV. In January, the project sponsored the participation of the national rabies coordinator in a training workshop at the EU Rabies Reference laboratory, ANSES, France, where she learned to apply a filter paper technique to collect blood from shot foxes for subsequent rabies antibody detection tests. In February, the PAZA II Laboratory Expert provided a sample panel of 10 positive and negative formulations prepared in Latvian National Rabies Reference Laboratory, Institute BIOR for use in the luminescent microscopy test. Since the osteotome and luminescent microscope had not been commissioned by the time of that mission, the Laboratory Expert could not provide practical training (Annex 6). However, the equipment for rabies diagnostic work was commissioned a short while later and it became possible for the ISUV staff to perform the tests. In her report of June 2015, the Laboratory Expert confirmed that the tests had been done proficiently (Annex 7). In conclusion, the basic diagnostic methods were established for rabies diagnosis by the end of the third reporting period. 3.3.4.6 Monitor the efficacy of the vaccination programme by collecting specimens during the post- vaccination period following each vaccination campaign. The project team supported the application of the post-vaccination monitoring strategy in accordance with the terms of reference. The DSE used the monitoring plan to specify the number of samples to be collected following the campaign. The procedures that were previously used for the collection, packaging, transportation, analysis and reporting of results to the veterinary directorate were again followed. The project negotiated with the Ministry of Environment (MoE) for permission to shoot selected foxes in all 36 districts and permits were issued promptly. The project s local Wildlife Expert and National Rabies Coordinator (NRC) then visited the selected districts to train hunters in the collection of samples from shot foxes in the designated hunting areas. The NRC prepared a report on the ORV campaigns that was published in the hunters magazine (Plate 3) to inform them of their contribution to the national campaign. The project s local Wildlife Expert and the President of the hunters federation were very active in visiting the field to cajole and encourage hunters to fulfil the quotas of foxes to be sampled. Specimens were submitted via the postal courier system that the project had established but due to the slow rate of specimen submission, the Wildlife Expert made follow up visits to encourage hunters to complete the activity. The DSE finalized the report of the two ORV campaigns completed in 2014 (Annex 8.2). The spreadsheet of all expenses incurred in the collection, transport and analysis of monitoring samples required by the EU Delegation was updated. This will continue to be refined and updated as costs are clarified, especially related to laboratory tests. 35

Improving consumer Protection Against Zoonotic diseases Phase II EuropeAid/133990/C/SER/AL Plate 1 - The PAZA Media Liaison Expert addresses teachers at a meeting in the Ministry of Education and Sport, Tirana Plate 2 - A teacher explains the Oral Rabies Vaccination campaign to a class of pupils at a school in Pogradec. Plate 3 The National Rabies Coordinator prepared a report on the 2014 Oral Rabies Vaccination campaign that was published in the hunters magazine Natyra 36

Improving consumer Protection Against Zoonotic diseases Phase II EuropeAid/133990/C/SER/AL Plate 4 - Positive case no. 2 Mediastinal lymph node of a bovine with generalized tuberculosis. [Photo: Courtesy of Prof Xh Koleci] Plate 5 Bovine tuberculosis - Positive case 2: Histopathological view: fibrotic granuloma, encapsulated caseous necrosis [Photo: Courtesy of Prof Xh Koleci] Plate 6 - Positive case no. 1 Mycobacterium bovis grown in Lowenstein-Jensen medium [Photo: Courtesy of Prof Xh Koleci] 37