The UK will provide up to £6,35m for GALVmed (Global Alliance for Livestock Veterinary Medicines) core unrestricted funding for 63 months (April 2012 - June 2017). A part of this funding (up to £2.5m) may be used to complete registration and commercialisation of a novel vaccine and a drug against porcine cysticercosis in pigs for which funding from the programme portfolio is no longer available. The total fund also include u p to £100,000 which DFID will use for an independent evaluation of GALVmed in the year 3.
DFID will provide these funds in partnership with the Bill and Melinda Gates Foundation, who will contribute US$42,100,000 to GALVmed to advance innovations and provide high quality, affordable and accessible diagnostics, drugs and vaccines for specified animal diseases to poor livestock keepers.
What need we are trying to address?
An estimated 75% of the poor live in rural areas. These people keep livestock as an important part of their livelihood as a key source of income and the primary form of savings and insurance (1) . This is why livestock is often attractive to poor people as the best option for improving livelihoods and escaping poverty.
The majority of poor livestock keepers live in remote areas with no, or very limited access to affordable and good quality animal health products such as rapid diagnostic tests, drugs and vaccines to deal with the constant threat from livestock diseases. Approximately 25% of their livestock die yearly because of preventable animal diseases (2) . Some of these diseases, such as Porcine Cysticercosis or Rift Valley fever, are naturally transmitted from animals to humans (zoonoses) and pose significant public health risks, while others such as Newcastle disease or contagious caprine pleuropneumonia affect poultry and small ruminants, which are often owned by woman.
Pharmaceutical companies do not find it profitable to invest in a portfolio of new animal health products targeted specifically at the needs of poor livestock keepers. To date the private sector remains largely uninterested as the situation on the ground in developing countries has not improved in terms of weak purchasing power by poor people, poor infrastructure, high commercial and political risks, gaining regulatory approvals and protecting valuable intellectual property. In addition, the costs of doing business in numerous small, diverse and fragmented markets are high and challenging. At the same time, many developing countries have neither the capacity to produce and license new products, nor the means to ensure animal health products are of high quality and safe. Financial support may also be required in order to ensure good manufacturing practice is subsequently followed during vaccine manufacture. Therefore, vaccines and medicines against animal diseases that affect livestock owned
1 IFAD, DANIDA, World Bank, DAAS, (2004). Livestock Services and the poor. A global initiative
Collecting, coordinating and sharing experiences. Rome, March 2004, p.152.
2 AU-IBAR (2012). Impact of livestock diseases in Africa. (http://www.auibar.org/index.php?option=com_flexicontent&view=items&cid=101&id=288&Itemid=148)

by poor people are either lacking, or are of low quality and pose additional risk because of cheaper alternatives of questionable quality and adulteration which could easily generate microbial resistance and threat to human health (3) , or not available in a form that is appropriate for use in a developingcountry villages (4) .
What we will do to tackle these problems?
DFID will support GALVmed through unrestricted core funding to address the on-going market failure and constraints in the delivery of products that are critical to protecting the health and productivity of livestock in Africa and Asia. DFID set up GALVmed in 2005 as an independent not-for-profit organisation to address the gaps and weaknesses identified above and to provide a mechanism for meaningful involvement of the private sector to combat specified animal and zoonotic diseases of particular importance to poor people who own livestock and enable them to improve their livelihoods.
During the Phase 1 GALVmed has made a significant progress in facilitating the development of a vaccine and a drug for Porcine Cysticercosis, and important zoonotic disease. This work is well advanced and requires additional funding for completion, which is no longer available due to the change in BMGF policy. For vaccine, trials have been completed and a manufacturer (in India) for large scale production of the selected vaccine (TSOL18) identified and contracted. For the drug
(Oxfendazole) - target animal studies have completed and manufacturer in Morocco being contracted.
Registration dossier is to be submitted in early 2012. Market studies to evaluate the use of the vaccine as public or private good in Africa and Asia have been concluded, a final report is expected in early
2012. A manufacturer has been identified in Senegal to bottle oxfendazole provided by Merial (owns the right to commercialise it) and to sell it in Africa.
Who will be implementing the support we provide and why?
GALVmed is the first (and currently only) organisation of this kind in the area of animal health operating in Africa and Asia. It has day-to-day operational independence from donors, and a governance and legal structure to bring together public and private sector research and innovation with commercial discipline to make the often difficult R&D ‘stop/ go’ decisions. GALVmed has already in place over 120 partnerships and 80 legal agreements with these organisations.
GALVmed will continue to build on previous work undertaken in Phase 1 between 2008 and 2011 and funded by DFID and the Bill and Melinda Gates Foundation (BMGF). GALVmed is focused on animal diseases (i.e. Rift Valley fever, East Coast Fever, Newcastle disease and Porcine Cysticercosis, bovine and caprine contagious pleuropneumonia, sheep pox and goat pox, peste des petits ruminants) which significantly contribute to poverty by causing the death of animals (up to 50-80%, depending on the disease) and loss of income. These diseases have the potential to result in annual losses to national economies ranging from US$16-240million/year (5) . Two of the diseases addressed by GALVmed have the potential be naturally transmitted from animals to humans (zoonoses) (i.e. Rift Valley Fever,
Porcine Cysticercosis). This results in loss of human lives and significant public health costs.
In partnership with local manufacturers and distributors, GALVmed has already made two new
3 Vudrico, P., Kikomeko,R., Majalija, S. (2011). Evaluating pricing and affordability of veterinary drugs among livestock farmers: A case study of Mityana district in central Uganda. Libestock Research for Rural Development,
23(7), 2011.
4 AU-IBAR (2004). The veterinary pharmaceutical industry in Africa: a study of Kenya, Uganda and South Africa.
African Union/Interafrican Bureau for Animal Resources, Nairobi, Kenya.
5 AU-IBAR (2012). Impact of livestock diseases in Africa. (http://www.auibar.org/index.php?option=com_flexicontent&view=items&cid=101&id=288&Itemid=148)

vaccines for East Coast Fever and Rift Valley fever widely available to poor livestock keepers in Africa.
A range of at least 9 new products are in the pipeline. A Proof of Concept has been obtained for 5 products (e.g. 2 new multivalent vaccines for Rift Valley Fever virus and Lumpy Skin Disease virus for sheep and goats; 3 new Newcastle disease vaccines); 3 new products have been developed and validation tests are close to completion (e.g. ovine& bovine Rift Valley fever penside tests, a porcine cysticercosis vaccine); 1 product registration dossier is close to completion (e.g. a drug for Porcine
Cysticercosis). Transfer of technology for manufacturing of ECF vaccine is close to completion while the distribution campaign has been accelerated. Manufacturing has been set up for 3 new products
(i.e. for Porcine Cysticercosis and Newcastle disease).
GALVmed will provide affordable and practical solutions to poor people in Africa and Asia to protect their livestock, their own health and livelihoods, and increase household incomes, assets and human nutrition, and improve public health. Over the next five years, GALVmed’s outputs will be

The development and delivery of 5-7 new animal health control products, such as rapid field diagnostic tests, drugs, and vaccines for at least 8 diseases that have the potential to cause significant losses to poor livestock keepers, and impact on their health;

The development of livestock policies and frameworks to create a better enabling environment for investment in product development and delivery in developing countries, and;

Increasing the capability and capacity of local manufacturers and distributors to deliver animal health tools and services to rural areas through a better understanding of local markets and access activities directly linked to the products.
Strategic Case
A. Context and need for a DFID intervention
What is the need for intervention?
It is estimated that some 1.4 billion people continue to live in extreme poverty on less than US$1.25 a day. Among those, there are between 500m to 900m livestock keepers that reside in remote rural areas of developing countries. Their living conditions remain poor, and they depend partially or fully on livestock for their livelihoods for food, trading and transportation services (IFAD, 2011 (6) ,
McDermott and others 2010 (7) , Thornton and others, 2002 (8) ). At least 50% of the cash income of farmers in sub-Saharan Africa is derived from the sale of livestock products (SWAC-
OECD/ECOWAS, 2008) (9) .
Livestock are at risk from many diseases (e.g. viral, parasitic and bacterial), resulting in major losses and impediments to growth in many developing countries. Approximately 25% of total livestock population die annually because of preventable animal diseases. At an individual level, the losses to their owners are in assets and household income and nutrition (e.g. loss in meat, milk, hides and
6 IFAD, (2011). Rural Poverty report 2011. International Fund for Agricultural Development, 00142 Rome, Italy.
7 McDermott, J.J., Staal, S.J., Freeman, H.A., Herrero, M., Van de Steeg, J.A. (2010). Sustaining intensification of smallholder livestock systems in the tropics. Livestock Science, doi (10.1016/j.livsci.2010.02.014).
8 Thornton, P.K., Kruska, R.K., Henninger, N., Kristjanson, P.M., Reid, R.S., Atieno, F., Odero, A., Ndegwa, T.
(2002). Mapping poverty and livestock in developing countries, ILRI, Nairobi, Kenya.
9 SWAC-OECD/ECOWAS (2008). Livestock and regional market in the Sahel and West Africa Potentials and challenges. p.170.

eggs), and illness and death in the case of diseases naturally transmitted from livestock to people
(i.e. zoonoses) which pose significant burden on public health services. These diseases have the potential to cause annual losses to national economies ranging from US$16-240million/year (10) .
While livestock continue to provide a vital contribution to national food security and economies in developing countries, it remains very vulnerable to animal diseases, particularly in rural areas. Due to privatisation of veterinary services, poor livestock keepers cannot either afford or are unlikely to gain easy access to services they need, or they have to travel long distances to get it (11) . At the same time, they lack assess to high quality, affordable and simple to use rapid field diagnostic tests, drugs and vaccines that are available and affordable in small packs suited to the herd or flock size in order to improve their livestock production and productivity and enable access to markets to increase their incomes. The private sector has very little incentive to develop these products on their own because the costs and risks are high, and markets are not large enough to justify the investment (12) . As a consequence, demand from poor livestock keepers for these products and services remains largely unmet by a supply side, further undermining their ability to ensure food safety for their own families and lift themselves from poverty.
However, where the costs and relevant risks can be shared, the private sector is willing to engage on a public good basis, and in some cases semi-commercial basis. After consultations between DFID and the pharmaceutical industry in 2005, DFID established GALVmed (Global Alliance for Livestock
Medicines) as a not-for-profit organisation to address the on-going gaps and weaknesses in translating research into products and then commercialising these through public-private partnership.
Since its establishment, GALVmed has attracted significant funding from the Bill and Melinda Gates
Foundation (BMGF) and the European Commission to tackle specified animal diseases such as Rift
Valley fever (13) , Newcastle disease (14) , East Coast fever (15) , porcine cysticercosis (16) , including contagious bovine pleuropneumonia (17) , contagious caprine pleuropneumonia (18) , Peste des Petits
10 AU-IBAR (2012). Impact of livestock diseases in Africa. (http://www.auibar.org/index.php?option=com_flexicontent&view=items&cid=101&id=288&Itemid=148)
11 FAO (2012). Pro-Poor Livestock Policy Initiative. A public choice approach to the economic analysis of animal healthcare systems (by Ana Riviere-Connamond). PPLPI Working Paper 11.
12 AU-IBAR (2004). The veterinary pharmaceutical industry in Africa: a study of Kenya, Uganda and South Africa.
African Union/Interafrican Bureau for Animal Resources, Nairobi, Kenya.
13 Rift Valley Fever (RVF) - A viral disease that primarily affects large and small ruminants but also has the capacity to infect humans (zoonosis). Infection can cause severe disease in both animals and humans. The disease also results in significant economic losses due to death and abortion among RVF-infected livestock.
14 Newcastle disease (ND) – A highly contagious viral disease of birds affecting many domestic poultry and wild avian species. Velogenic strains produce severe nervous and respiratory signs, spread rapidly and cause up to
100% mortality in unvaccinated birds. Mesogenic strains cause coughing, affect egg quality and production and result in up to 10% mortality.
15 East Coast Fever (ECF)
– A tick-borne protozoal infection of cattle in East and Central Africa. It is transmitted by infected ticks, Rhipicephalus appendiculatus . ECF is one of the major disease constraints to cattle development in Africa.
.
16 Porcine cysticercosis (PC) - A zoonotic helminth (pig tapeworm) affecting primarily pigs and humans
(zoonosis). Symptomatic disease from Taenia solium cysts in the brain of humans is referred to as neurocysticercosis and is the most common tapeworm infection of the human brain worldwide. Cysticercosis is the most common cause of symptomatic epilepsy worldwide.
17 Contagious bovine pleuropneumonia (CBPP) – A highly contagious respiratory bacterial disease of cattle with high mortality rates.
18 Contagious caprine pleuropneumonia (CBPP) – A highly contagious respiratory bacterial disease of goats with high mortality rates.

ruminants (19) , sheep pox and goat pox and lumpy skin disease (20) . Rift Valley fever and porcine cysticercosis are naturally transmitted from livestock to people (zoonoses).
Women are particularly susceptible to some zoonotic diseases due to their exposure to milk, manure, raw meat and animal birth fluids. These diseases add to the health problems of the poor, particularly those with suffering from Tuberculosis or HIV/AIDS. Recently published reports (21, 22) on the gender and social dimensions of livestock keeping in developing countries suggest that the majority of those affected by HIV/AIDS are woman in Africa. HIV/AIDS affected households are the most vulnerable to zoonotic diseases, food insecurity and poverty. Woman also often own poultry and small ruminants.
What we will do to address the need and why?
DFID will support GALVmed to increase the impact and effectiveness of our investment to benefit poor livestock keepers. As a single management unit, GALVmed has been very successful in converting the public and private research outputs into drugs and vaccines that are acceptable and affordable. GALVmed does this through better targeting and coordination, improved research management, active engagement of the private sector, and by appropriately addressing issues that may arise at technical stages to ensure effective delivery chains.
At the research level, in partnership with private sector, local manufacturers and distributors,
GALVmed has already has already made two new vaccines (i.e. for East Coast Fever and Rift Valley fever) widely available in Africa. A range of at least 9 new products are in the pipeline (e.g. 2 new multivalent vaccines for Rift Valley Fever virus and Lumpy Skin Disease virus for sheep and goats; 3 new Newcastle disease vaccines; validation tests are close to completion for ovine& bovine Rift
Valley fever penside tests, and a porcine cysticercosis vaccine; product registration dossier is close to completion for a drug for porcine cysticercosis).
At the field level, for example, more than 170,000 cattle have been vaccinated and protected from infection with East Coast Fever in East Africa. GALVmed facilitated registration of an existing monovalent Rift Valley Fever vaccine, already used on more than 5,000,000 animals in South Africa with field trials initiated in Kenya and Senegal. Around 800,000 chickens in Africa and Asia are being vaccinated through field pilots against highly contagious Newcastle disease with the aim to set up sustainable distribution systems. The market assessment framework and baseline of current knowledge on 4 diseases (i.e. ECF, ND, porcine cysticercosis, and RVF rapid test) have been conducted and are integrated into the distribution and delivery strategies.
Transfer of technology for manufacturing of ECF vaccine is close to completion while the distribution campaign in Africa has been accelerated. Local manufacturing has been set up for porcine cysticercosis and Newcastle disease.
How this intervention links to DFID strategic policy objectives?
One of DFID’s major goals is to reduce poverty and hunger and to accelerate pro-poor growth.
DFID RED agriculture research team priorities are to strengthen our research work on innovation in
Africa. Support to GALVmed will address specific animal diseases which have the potential to significantly impact on poverty reduction and rural economic growth in developing countries, and improving human health and nutrition.
19 Peste des Petits Ruminants (PPR) – A highly contagious viral disease of sheep and goats with high mortality rates. The virus is a close relative of Rinderpest virus in cattle.
20 Sheep Pox and Goat Pox (SPGP) and Lumpy skin disease (LSD) virus of cattle – Highly contagious viral diseases of sheep and goats (SPGP) and cattle (LSD) with potential to cause significant economic losses.
21 GALVmed, 2011: (Prepared by Beth A. Miller) The Gender and Social Dimensions to Livestock Keeping in
South Asia: Implications for Animal Health Interventions. 7 March 2011, p.48.
22 GALVmed, 2011: (Prepared by Beth A. Miller) The Gender and Social Dimensions to Livestock Keeping in
Africa: Implications for Animal Health Interventions. 7 March 2011, p.48.

B. Impact and Outcome that we expect to achieve
Impact
GALVmed aim is to improve the health of livestock and increase food security and human health of small/ poor livestock keepers in low-income countries.
The outcome GALVmed expects to achieve is to make available and accessible novel rapid diagnostic tests, drugs and vaccines to poor livestock keepers in developing countries that are affordable and technically suitable to combat specific animal diseases. High quality drugs and vaccines have demonstrated the potential to significantly reduce losses and increase productivity and production. For example, a recent study comparing East Coast Fever unvaccinated and vaccinated
Zebu calves demonstrated the vaccine protection of 97% against the disease. It was also shown that the vaccination has increased the net value of the calf by up to US$30 due to increased milk yield, higher market value of vaccinated calves and the number of extra calves sold (23) . A preliminary finding from the GALVmed’s project on the vaccination of village poultry against Newcastle disease which is currently underway indicates a 30% increase in chickens in a study village.
Appraisal Case
A. What are the feasible options that address the need set out in the Strategic case?
In assessing the strength of evidence, we consider the following combined criteria: a) Delivering rapid tests, drugs and vaccines for animal diseases – ability to facilitate private sector development and deliver a range of high quality research products on time, within budget and to accepted quality standards. b) Delivering partnerships - partners selected on quality of research and technical product delivery; clear roles and responsibilities and performance management systems, effective and efficient plans in place to identify and address failures of partners to carry out the tasks. c) Developing markets for new research control tools – developing private sector partnership, and building on willingness of farmers to participate in disease control to maximise benefits at the household level; ensure right mix of field and empowerment methods which are gender sensitive, develop a results framework with focus on sustainability. d) Governance and management – strategy and business plan with clear focus on delivery, results and impact, effective organisation capability and change management, project management, leveraging support, intellectual asset management including access and commercialisation, M&E, reporting.
The following options were considered and fully argued in the section C (costs and benefits of each option) below: a) Option 1 - GALVmed – GALVmed has comparative advantage, track record and unique position as a not-for-profit organisation which can broker private-public sector partnership to
23 Babo Martins, S., G. Di Giulio, G. Lynen, A. Peters, J. Rushton, (2010) Assessing the impact of
East Coast fever immunisation by the infection and treatment methods in Tanzanian pastoralist systems. Preventive Veterinary Medicine Volume 97, Issues 3 –4, 1 December 2010, Pages 175–182

assist in the delivery of new technologies to poor livestock keepers in developing countries.
GALVmed has secured significant funds from the Bill and Melinda Gates Foundation for the disease platforms projects. b) Option 2 – Engage the private sector through pull-mechanisms . This would include an open competition to identify suppliers to essentially establish a similar GALVmed type organisation.
c) Option 3 – Counterfactual: Do not invest in GALVmed and spend on other research options through other channels . In line with RED Agriculture Research Team innovation paper, we could save just over £6m to invest into our research priorities through a delivery of three interlinked objectives: (i) speeding up adoption of technological innovation by smallholders at scale in a cost effective and sustainable way, (ii) strengthening the evidence base by exploring the constraints facing small-holder farmers and the ways in which these might be overcome, (iii) increasing the availability of technological innovation through the
B. Assessing the strength of the evidence base for each feasible option
In the table below the quality of evidence for each option is rated as either Strong, Medium or
Limited. translation of new and existing research into new products and their commercialisation by working with both the public and private sector. GALVmed is already fully addressing these objectives successfully.
Option
1
Evidence rating
Strong evidence – No similar organisation to GALVmed exists. GALVmed is offering solutions by delivering new technologies and making them available and affordable to poor livestock keepers in developing countries and facilitating markets for these products.
Strong evidence of creating partnerships to deliver new technologies by stimulating markets.
Strong evidence that the GALVmed Board is determined to ensure that GALVmed continues to perform as an effective and well managed organisation.
We consider that Option 1 – GALVmed is the only feasible option to undertake Phase 2 activities.
We set out the Theory of Change for Option 1 which underpins our evidence ratings. a) Input

D FID contribution of £6,345,773. BMGF contribution of up to US$41,2 million (approx:
£25,75 million) b) Process (Activities)

Continued support to GALVmed in order to continue organisational and technical operations in Africa and Asia, and other regions as outlined in the logframe indicators.
c) Outputs

Develop, register, and facilitate the production and availability of 5 - 7 veterinary vaccines, pharmaceutical or diagnostic products by 2017 that impact on the needs of the poor livestock keepers

Facilitate sustainable market development & access programmes in a scalable way for a registerable portfolio of products

Advocate and create partnerships to achieve impact on animal health for poor farmers


Consolidate GALVmed as a well performing organisation d) Outcome (Purpose)

Make available and accessible animal health products to poor livestock keepers in low income countries that are affordable and technically suitable. e) Impact (Goal)

Improve the health of livestock and increase food security and human health of small/ poor livestock keepers in low-income countries.
What is the likely impact (positive and negative) on climate change and environment for each feasible option?
Categorise as A, high potential risk / opportunity; B, medium / manageable potential risk / opportunity; C, low / no risk / opportunity; or D, core contribution to a multilateral organisation.
Option Climate change and environment risks and impacts, Category (A, B, C, D)
1
2
C
C
Climate change and environment opportunities, Category (A, B, C, D)
B (with a potential to be A)
C
There are very low anticipated impacts or risks to both environment and climate associated with this intervention, but a considerable number of opportunities in both areas. This intervention will contribute to improve animal health and security of livelihoods for a large number of farmers across the developing world.
From a more general point of view this will have a very marked -albeit slightly indirect- beneficial impact on the environment because it will reduce the amount and level of environmentally consumptive and degrading behaviours/choices that farmers/livestock keepers are forced to make when their livestock are struck down by illness or die as a result of it. Some examples include: migration into marginal areas leading to environmental degradation and conflict; the cutting down of trees or shrubs that would normally be kept and maintained as source of animal fodder to obtain some revenue from wood/charcoal; increased hunting of wild animals for bush meat and in some extreme cases poaching (24) .
From a more specific point of view it can also be argued that the development of vaccines for livestock, which includes poultry and cattle, can help contain and possibly eradicate the spread of devastating diseases that could be transmitted, either in their original ore mutated form, to wild animal populations. This is a particularly important aspect as it could trigger a potentially catastrophic backlash for entire ecosystems (25) across countries and possibly even continents if for example long distance migratory land animals or birds were to become infected (26) .
In terms of its impact on climate change, this intervention presents some clear opportunities to reduce vulnerability, improve resilience and increase adaptability of a large number of farmers across the developing world. This would be effectuated by improving their ability to control and even
24 Bromley, D., Cernea, M.M., (1989). The management of common property natural resources, some conceptual and operational fallacies. World Bank Discussion Papers No 57. The World Bank: Washington DC.
25 Altizer, S., Bartel, R., Han, A.B. (2011). Animal Migration and Infectious Disease Risk; Science 21 January
2011: Vol. 331 no. 6015 pp. 296-302
26 Bethany J. H, Fouchier, R. A. M., Klaassen, M. (2011). Host behaviour and physiology underpin individual variation in avian influenza virus infection in migratory Bewick's swans; Proceedings of the Royal Society B, Proc
R Soc B 6 July 2011: rspb.2011.0958v1-rspb20110958.

eliminate the effect of existing new and emerging diseases that could affect not only their livelihoods (27) but also their health and that of their families (28) . This becomes particularly relevant in the context of a changing climate where vector borne diseases in particular are expected to expand their range and migrate to areas that were previously beyond their reach (29, 30) .
This intervention does not appear to be susceptible to climate shifts or variations and therefore there is very little or no risk that future climate variations and/or variability may determine any foreseeable risk to success of its implementation.
C. What are the costs and benefits of each feasible option? a) Option 1 - GALVmed :
In terms of value for money, funding GALVmed will leverage significant resources of up to
US$42,100,000 from BMGF to fund research for specified animal diseases in Phase 2. This is nearly a 100% increase in the BMGF funding to GALVmed compared to their funding for the Phase 1
(US$22 million). DFID’s core funding for the Phase 1 was around £3.7 million, and will be increased for up to £2.5 million to bring the total DFID funds to up to £6.25 million. The overall DFID : BMGF funding proportion is approximately 1 : 4 at the current exchange rate. GALVmed’s current Business
Plan envisages that GALVmed will become a self-financing organisation by the end of this funding period. Steps are already being taken to diversify their funding sources.
BMGF funds will be used to facilitate production and delivery of new products for specific animal diseases, including stimulating markets for these products. The funding is primarily allocated across disease projects and new technologies, including specific disease market development activities, policy and external affairs, direct project costs, indirect costs and capital expenditure and M&E at the projects level.
DFID funds will be used to fund core costs of GALVmed organisational management, delivery and monitoring. These costs include staff, travel and subsistence, recruitment costs, governance and legal costs, office costs, consultancy fees, fundraising and marketing, equipment, and monitoring and evaluation at an organisational level. GALVmed has procures in place to ensure that no activity is double funded by DFID and BMGF funds , including overheads. A part of DFID’s funding will also be used to capitalise on the well advanced work already funded by BMGF on a drug and a vaccine development for porcine cysticercosis, for which the BMGF funds are no longer available due to the recent change in their policy on funding research related to pigs as an animal species.
Our support to GALVmed will address an on-going under-investment by the private sector in the technology, which smallholders in Africa could utilise (see Option 2 below for reasons). Firstly,
GALVmed, as no other current DFID’s investment in animal health, offers market based approaches.
It will utilise the market economy to engage low-income people as customers and will offer them socially beneficial products at affordable prices. To achieve this, GALVmed will facilitate sustainable partnership between research innovations, manufacturers, distributors and end users by incorporating demand stimulation into their bottom of the pyramid models. This will accelerate wider uptake of new technologies and provide all the participants in the chain with improved incomes, and generate growth.
27 Shemsanga, C., Omambia, A.N., Gu, Y. (2010): The Cost of Climate Change in Tanzania: Impacts and
Adaptations; Journal of American Science 2010; 6(3): 182-196].
28 Enserink M. (2010): Humans, Animals —It's One Health. Or Is It? Science 15 January 2010: 266-267.
29 Enserink M. (2008): Exotic Disease of Farm Animals Tests Europe's Responses; Science 8 February 2008:
Vol. 319 no. 5864 pp. 710-711
30 Gibbs, E. P, J., Tabachnick, J.W., Holt, T.J., Stallknecht, D.E. (2008): U.S. Concerns over Bluetongue;
Science 16 May 2008: 872.

By funding GALVmed, DFID significantly reduces transaction costs, given the management through a single and independent organisation which has established systems and procedures in place to run competitions and ensure delivery. In particular, funding GALVmed avoids the potential for duplication of donor funded activities. GALVmed has a structure in place to meet a range of donor specific requirements (e.g. maintaining a development/not-for-profit purpose, reporting and accountability) whilst imposing a coordinating mechanism on donor activity in the animal health arena.
GALVmed now operates in 15 countries in Africa and 2 in Asia. GALVmed’s performance to date has been assessed as successful in DFID ’s Annual reports, including the Project closure report for our support for the Phase 1 (2008-2011). Governance and management issues (i.e. a review of new leadership needs) have been identified and are being successfully addressed by the Board to ensure
GALVmed's delivery is on course. The new Business Plan clearly sets out activities and milestones for delivery, including plans for GALVmed to become self-financed at the end of this period.
In terms of the benefits of bringing a new animal health product to market, pharmaceutical industries generally estimate that bringing one new animal health product to market tends to vary greatly. In terms of average time it could take up to 5-10 years. In terms of cost, it should be in the range of
US$20100 million per product (£13-66 million). The costs invested in GALVmed for the next 5 years in are approximately £33 million. If, for example, we take a period of five years and average £13 million per products, initial calculations at the point of commercialisation would be based on following conservative assumptions:

Industry – 1 product, average time 5 years, average cost of cost £13 million

GALVmed – 5 products, average time 5 years, cost £33 million (average cost of £6.6 million per product, which is just above from the total DFID contribution)
If the industry costs are in order of £13 million, the benefit/cost ratio (BCR) for this investment would be in order of approximately 1.96 :1.
GALVmed will use a part of DFID funds will be used to fund well advanced work on porcine cysticercosis because BMGF funds are longer available for this project due to their change in policy.
GALVmed is very close to finalising production and commercialisation of a vaccine and a drug for this disease in pigs. This is a great success as no such vaccine exists. Six pilot projects (in Africa and
Asia) will be implemented to deliver integrated control programs, directly benefiting initial 150-200 households participating in trials. Porcine cysticercosis is a zoonotic helminth (pig tapeworm) affecting primarily pigs and humans. Symptomatic disease from Taenia solium cysts in the brain of humans is referred to as neurocysticercosis and is the most common tapeworm infection of the human brain worldwide. Cysticercosis is the most common cause of symptomatic epilepsy worldwide. Various statistics indicate that 1 million people in Africa and Asia have active epilepsy attributable to neurocyticercosis resulting in approximately 50,000 deaths per year. For example, the monetary burden of the disease in Eastern Cape is estimated annually at US$18-34 million. The availability of a vaccine and a medication for pigs, combined with effective control could save this amount per year.
A decision not to provide support to GALVmed core funding will directly and significantly impact on their ability to continue as a not-for-profit charitable organisation and deliver research funded by the
Bill and Melinda Gates Foundation. GALVmed would have to seek alternative sources of core funding from the private sector in order to help fill the funding gap for core costs, such as salaries. In the current financial climate it is unlikely that the sudden shortfall in GALVmed’s funding could be made up easily from the private sector to enable GALVmed to function as an organisation. By withdrawing support to GALVmed now DFID would indicate a shift in our policy on engaging with private sector in addressing animal health in developing countries, and would cause great difficulty for GALVmed and the BMGF. Given the leading role that GALVmed plays in supporting delivery of veterinary drugs and vaccines to poor people, it would undermine UK position on support to feeding

the world poor people with high-quality protein, thus contributing to food security and nutrition. b) Option 2 – open competition
There is no organisation similar to GALVmed which is established and operational as a PDP to address these gaps in the area of animal health in developing countries. An alternative to DFID support to GALVmed’s core functions, would be to launch an open competition for a set of partnerships to establish a new PDP type arrangements. This would enable DFID to use competition to bring together new partnerships around a number of targeted products or animal diseases.
To date the private sector remains largely uninterested as the situation on the ground in developing countries has not improved in terms of poor infrastructure, high commercial and political risks, gaining regulatory approvals and protecting valuable intellectual property. In addition, there are also difficulties in accessing finance, and the costs of doing business in numerous small, diverse and fragmented markets are challenging.
The costs associated with establishing a new PDP would not represent good value for money for
DFID’s investment. This would come at a cost both in terms of human and financial resources. There would be a significant delay in implementation, and no guarantee that the competition and procurement process would be successful. Moreover, it is highly unlikely that providing funds to another PDP organisation would leverage the same amount of funds from other donors, including
BMGF. For this reason it is not considered a feasible option. c) Option 3
– Counterfactual
The counterfactual would be not to invest in GALVmed or a PDP type arrangement for getting animal health products into use. We would continue to have an engagement in animal health product development and delivery through our investments in the CGIAR (the CRP on Milk, Meat and Fish as well as the CRP on Agriculture and Nutrition), as well as through BBSRC (CIDLID) and potentially in the Agriculture Pull Mechanism Initiative, which may look at livestock vaccine development for PPR.
These programmes would still enable us to have an offer on innovation in animal health, although at a lesser scale.
However, most of these existing programmes in animal health (e.g. CIDLID, bovine Tb) are geared on product development only. Whilst the APMI may play an important role in pulling livestock vaccines into use, at this stage, details are not confirmed and our funding to it not approved. Whilst one would anticipate continued progress in this field of developing new products and getting them into use, the pace of innovation is likely to continue to be slower under this option, without a dedicated mechanism to do this. Apart from GALVmed, there is no currently donor funded project in place in the area of animal health which brings together both research product development and improving access and affordability to new and high quality drugs and vaccines by targeted populations through markets in developing countries, and does this at scale. Currently, GALVmed is the only organisation that provides a comprehensive, robust, and a cost-effective approach to address this major gap for a number of animal diseases of importance to poor. Without DFID’s financial and technical support to GALVmed, its capacity would be significantly curtailed.
Conclusion: Option 1 – GALVmed represents the best value for money for DFID as GALVmed will continue to build on their successes in delivery of a number of new rapid tests, drugs and vaccines for animal diseases in developing countries.
D. What measures can be used to assess Value for Money for the intervention?
GALVmed will bring together the key players with the most advanced technologies developed. It will select potential research partners through a combination of searching for relevant expertise,

invitation, open call and peer-review. As required by DFID, GALVmed will ensure that third party organisations funding provides value for money.
DFID will monitor GALVmeds performance and delivery through regular contact and attendance at the Board meetings, including regular Annual reviews. GALVmed’s logframe indicators and performance measurement framework will provide a sound basis for judging the success. The logframe also includes lessons learned from earlier work in Phase 1 in order to accelerate the number of technologies available for widespread use and adoption by poor farmers, including gender, and monitoring the impact.
GALVmed has recognised the need to present economic return on investment. Under the “Impetus
Strategy Paper ” work (which is ongoing), GALVmed has engaged world experts on livestock health economics to identify how relevant information may be gathered and presented in a user friendly way.
There is currently very little information on economic returns of research into animal health as currently no DALYs exists in animal health terms as they do exist in human health.
The wider benefits to poor people would be significantly greater when GALVmed’s products are used in terms of the number of animal lives saved and increased production and productivity as well as improving public health and nutrition. For example, the following outline the potential of the
GALVmeds work to contribute to measuring economic returns:

Rift Valley Fever (RVF) with Sheep Pox and Goat Pox (SPGP) and Lumpy Skin Disease
(LSD) – A monovalent RVF vaccine has already been used to vaccinate than 5,000,000 animals in South Africa, with field trials initiated in Kenya and Senegal. A multivalent RVF-
LSD/SPGP vaccine will be used to vaccinate at least 800 animals in registration trials and at least 150,000 animals during 3 campaigns to prime the vaccine market once vaccine is available commercially. RVF vaccine bank will be in place for Africa. There are more than 200 million cattle and 380 million small ruminants in Western, Eastern and Southern Africa.

Increased production of Newcastle disease vaccine suitable for village poultry - a combination vaccine suitable for village poultry is planned to become available by 2015. Pilot Projects in
Africa and Asia will impact on more than 120,000 households with an average of 8 chickens vaccinated 2.5 times per year. With commercialization, over 3 million vaccine doses are expected to be sold per years.

East Coast Fever (ECF) – realisation of sustainable regional vaccine production and supply could result in 1 million to 2.5 million cattle vaccinated, thus contributing to the steady reduction of ECF impact estimated at more than US$250 million a year with around 40 million cattle at risk per year. This could have a significant positive impact on environment as the use of insecticides to treat animals against ticks would be considerably reduced over the time.

Porcine Cysticercosis
– the vaccine (TSOL18 vaccine) and medication (Oxfendazole) will become widely available. Six pilot projects (in Africa and Asia) will be implemented to deliver integrated control programs, initially benefiting 150-200 households and to prime the markets.
We have already emphasised that some 1 million people in Africa and Asia have active epilepsy attributable to neurocysticercosis.

Contagious bovine pleuropneumonia (CBPP)
– an integrated control strategy will be delivered in at least 2 countries in Africa covering some 70,000 animals. If the appropriate control strategies, using improved vaccine are applied in Africa, this would have an effect of a 25% decrease in impact of the disease where the estimated annual cost is at least US$80 million/year per affected country. It is estimated that the benefit-cost ratio would be 2.24 : 1 for
Tanzania, 1.85 : 1 for Mali, and 2.89 : 1 for Ethiopia.


Contagious caprine pleuropneumonia (CCPP) – the development of a high quality production process for the CCPP vaccine will be finalised resulting in an increase in production and uptake. There are only two vaccine manufacturers in Africa (Kenya and Ethiopia) which currently produce just under 3 million doses altogether, which is not sufficient to cover their own market demand. Production is expected to increase to at least 4 million doses in Kenya and 1 million doses in Ethiopia per year with increased availability and access to the vaccine in non-vaccine producing countries.
These are some potential benefits that new technologies may have in protecting the lives of the animals, while at the same time improving human health and nutrition. Indirect benefits would be measured in costs of loss of animal productivity, impact on human health and further control.
Monitoring
GALVmed ’s Business Plan and the M&E Strategy requires data collection at the following three interconnected levels: a) Project level – each specific project will collect baseline data related to gender, socioeconomic impact and production data for cost benefit analysis by using the software tool for collection and analysis that was developed during Phase 1. Gender related data will be collected, disaggregated and analysed separately so that information on the impact of our projects on gender is not lost or diluted. b) Organisation level – will include ‘headline’ data from project level to evaluate GALVmed processes in order to improve the overall performance of GALVmed as an organisation.
GALVmed is currently finalising key performance indicators for each objective, and indicator protocols which will detail the methodology of measuring the indicators including components such as the baseline and targets, frequency of measurement and plans for analysis. This will be applied across all activities and projects including organisational monitoring and evaluation. GALVmed has appointed a Monitoring and Evaluation manager. c) External level
– will include partnership with other organisations that have the mutual objective of collecting and collating livestock data consistently. This will service the needs of the livestock communities to address the challenges faced. GALVmed will also collect data on the impact of diseases and interventions at a macro level to inform decision makers on which livestock disease have the most impact on poverty and therefore provide justification for investment and targeted intervention. Data collected at this level will be fed by the data at the project level and will be adapted to meet the needs of external audiences such as donors, academia, policy makers, and wider public.
DFID will initiate an independent evaluation of GALVmed in the year 3 of our new support. Evaluation plan will describe the proposed evaluation (e.g. purpose, key users, design and method, identification and contracting of evaluators, communication strategy) and how it fits with the existing evidence base and the monitoring strategy. This should follow GALVmeds established procedures.
E. Summary Value for Money Statement for the preferred option
GALVmed is an established partner with a proven track record in delivering value for money.
GALVmed will provide a critical and disciplined framework to help steer the research, with funding for the most promising animal health technological products (i.e. delivery of cheap rapid field diagnostics, drugs, and vaccines), and stimulate markets for these to ensure wider uptake in

developing countries.
Commercial Case
Direct procurement
A. Clearly state the procurement/commercial requirements for intervention
As per DFID’s procedures, we will sign an Accountable Grant (AG) with GALVmed. This AG will draw heavily on the Memorandum of Understanding previously used and incorporate some additional requirements and language around performance, payments and delivery. The AG is the most appropriate mechanism to engage GALVmed, as they are a not for profit organisation.
B. How does the intervention design use competition to drive commercial advantage for
DFID?
N/A. DFID will not go through a competitive tendering process for funding GALVmed. GALVmed will use a competitive process for commissioning work. GALVmed has also leveraged funds from the
European Commission on a VACNADA project. This project is close to completion and is widely recognised by African governments and others in significantly improving regional manufacturing capacity, scaling up production and ensuring high quality of products. GALVmed will continue to build on these linkages.
C. How do we expect the market place will respond to this opportunity?
DFID will not go to through a competitive tendering process for funding GALVmed. However,
GALVmed will build on their experiences and successes in subcontracting by getting the market to respond (e.g. East Coast Fever, Farm Africa franchise, Community animal health workers network).
GALVmed will, develop ‘last mile’ distribution models and a risk sharing model to support market development. To support this work, GALVmed will establish a Market Development Department with commercial leadership and objectives to upscale the uptake. GALVmed expects that this will result in
(a) better business and marketing skills of local producers and distributors resulting in increased sustainability of GALVmed linked products, (b) ensures that women are better supported to sustainably deliver in the market and (c) increases access to finance and resources through new incentives.
D. What are the key cost elements that affect overall price? How is value added and how will we measure and improve this?
DFID’s funds will be allocated for GALVmed core activities (i.e. operating and capital costs.
This will be measured through quarterly financial reports and attendance at GALVmed’s Board meetings.
E. What is the intended Procurement Process to support contract award?
As per DFID procedures we will sign an AG with GALVmed..
F. How will contract & supplier performance be managed through the life of the intervention?
Research and Evidence Division (RED) staff will maintain regular contact with GALVmed throughout its lifetime, and in particular will:

Receive and review annual written GALVmed’s reports that outline progress against the logframe and annual workplan - these reports will be shared with relevant DFID advisers. This

will also include at least 23 case studies per year for DFID’s communication purposes.

Undertake a DFID annual review and project completion report in line with DFID requirements;

Attend various GALVmed’s management meetings and field visits as deemed necessary; and

Plan for an independent evaluation of GALVmed in year 3.
DFID will use these opportunities to monitor and manage GALVmed’s progress and will proactively intervene and take remedial action as and when required should any concerns arise. DFID will undertake a formal annual review each year, the results of which will be shared with GALVmed, and published.
Quarterly financial invoices and reports will be checked by DFID on receipt and any queries will be raised immediately with GALVmed in order to clarify/resolve issues. Any ongoing concerns around their financial management will be acted upon and handled in accordance with DFID corporate procedures. This could involve but not necessarily be limited to referral to Accounts Department with a view to enforcing Accountable Grant conditions or brining in internal audit etc if deemed appropriate.
Indirect procurement
A. Why is the proposed funding mechanism/form of arrangement the right one for this intervention, with this development partner?
The AG will ensure that GALVmed conducts business in line with DFID requirements and expectations. It will require GALVmed to continue to work with a diverse range of partners and create and deliver public and private sector partnerships.
B. Value for money through procurement
This approach ensures strategic engagement and maximum development impact and value for money because:

It identifies key suppliers where innovation, value for money and impact are inherent in the design and thereby deliver improved quality.

Through market collaboration the agreement drives effectiveness and results in high quality products and competition.
GALVmed has successfully used this approach to facilitate the availability and access to the East
Coast Fever vaccine. The significant movement and development into other disease areas (Rift
Valley Fever, Newcastle Disease, and Porcine Cysticercosis) ensures us that this is the most appropriate funding mechanism.
Financial Case
A. What are the costs, how are they profiled and how will you ensure accurate forecasting?
The total cost of GALVmed Pha se 2 to DFID is estimated at £6,345,773 over 63 months starting in April
2012. A part of this funding (up to 2.5 million) may be used to complete registration and commercialisation of a novel vaccine and a drug against porcine cysticercosis in pigs for which funding from the programme portfolio is no longer available. The total fund also include up to £100,000 which
DFID will use for an independent evaluation of GALVmed in the year 3.

GALVmed will provide regular monthly financial updates to ensure DFID’s forecasting is as accurate as possible and draw on our experience of working with GALVmed in the past. The estimated break-down of DFID costs for the Phase 2 are outlined in the Table below:
PLSHL2 DFID Revised Summary – implementation date is 1 April 2012
DFID apportionment - Total Funding
£6.245m
Table: Expected DFID funding annually for 63 months
Year 1
Apr 12 - Mar
13
Year 2
Apr 13 - Mar
14
Year 3
Apr 14 -
Mar 15
Year 4
Apr 15 - Mar
16
Year 5
Apr 16 - Mar
17
Year 6
Apr 17 - Jun
17
TOTAL
TOTAL
Table:
1,247,868 1,173,481 960,342 1,332,968 1,101,131
Breakdown of funding via Outputs
429,983 6,245,773
Objective 1
Objective 2
Objective 3
Year 1
471,872
67,438
206,614
Year 2
559,729
78,037
170,274
Year 3 Year 4 Year 5
394,883 535,773 377,712
114,529 104,837 64,442
100,654 134,267 94,133
Year 6
203,384
34,700
50,687
141,212
TOTAL
2,543,353
463,983
756,629
2,481,808 Objective 4 501,944 365,441 350,276 558,091 564,844
429,983 6,245,773 TOTAL 1,247,868 1,173,481 960,342 1,332,968 1,101,131
B. How will it be funded: capital/programme/admin?
GALVmed will be funded from DFID
’s Research and Evidence Division’s Programme budget. Provision has already been made in this budget in order to accommodate these costs.
C. How will funds be paid out?
DFID will sign and AG with GALVmed. DFID have yet to finalise the exact payment schedule with
GALVmed, but it is anticipated that payments will be made in advance on a quarterly basis.
D. What is the assessment of financial risk and fraud?
DFID have a long and established relationship with GALVmed. The AG with GALVmed will outline the accounting and auditing requirements for the programme. If at any time DFID is not happy with
GAL Vmed’s financial management or audit controls, we will take all necessary steps to resolve the issue, including bringing in other DFID colleagues e.g. Internal Audit Department if deemed necessary.
E. How will expenditure be monitored, reported, and accounted for?
GALVmed will provide DFID with a copy of its Annual Audited Accounts and Annual Report which will set out the progress made against agreed work plan, logframe and objectives.

DFID will meet with GALVmed every 6 months to discuss the projects performance against its objectives and financial management.
Management Case
A. What are the Management Arrangements for implementing the intervention?
GALVmed has established organisational and management structures according to DFID’s and BMGF requirements, including the establishment of the Board and a management structure led by a Chief
Executive Officer. DFID attends the Board meetings as an observer.
GA LVmed’s governance structure consists of:

Board of Trustees will ensure the organization is on track to deliver and is doing so in an open, transparent and fair way. The management of GALVmed is the responsibility of the Trustees
(Board Directors) who are elected by the Members under the terms of the Memorandum and
Articles of Association. GALVmed currently has 12 members, 5 Founder Members, 7 Ordinary
Members, 9 Board Directors and 5 nominated Board Directors. Board Directors are recruited for their individual skill and experience. The Board of Trustees meet 4 times a year. The Board is supported by several sub-committees to whom some aspects of day to day accountability and governance are delegated.

Board Sub Committees will ensure that key milestones are reached, where applicable innovation and adaptation are built into delivery. There are 5 in total: the Committee’s primary roles are briefly described below. Each sub-committee has their own terms of reference and membership:

Technical SubCommittee’s (TSC) primary role is to provide an independent overview of
GALV med’s technical and R&D activities and strategies on behalf of the Board. Its main responsibilities are in relation to Projects (activity review and ensuring due diligence is undertaken), review of Technology Policies & Strategies and ensuring that an effective and efficient Expert Scientific Advisory Committee
 Finance & Audit Committee’s (FAC) primary role is to provide an independent overview of financial and non-financial matters on behalf of the Board. Its key responsibilities are to ensure effective Internal Controls and Risk Management Systems, to assess Fraud and Whistle
Blowing policies and incidents, oversee the relationship with the External Audit in addition to
Internal Audit, Investment Policy, Financial Planning and Reporting, Governance Review and
Institutional Audit

Policy & External Affairs SubCommittee’s (PEA) primary role is to provide an independent overview of GALVmed’s policy and external interactions and communications on behalf of the
Board. Its main responsibilities are in relation to Policy Setting and Execution (to ensure development and adoption of policies), External Affairs (strategy and links with external groups) and External Communication (oversight and compliance).

Global Access SubCommittee’s (GASC) primary role is to provide oversight and guidance on
GALVmed’s activities and strategies to address economic, social and political barriers to ensuring access and sustainable supply of GALVmedsupported products to the world’s poorest livestock keepers. The Committee’s key responsibilities are in relation to Regulatory
Environment, Manufacturing and Demand Management, Reliability of Supply, Pricing and
Positioning Policies and Compliance and Pharmacovigilance

 Remuneration & Human Resources Committee’s primary role is to provide an independent overview of remuneration and other human resource matters on behalf of the Board. In respect of Remuneration its key activities are to determine and implement a remuneration policy and on
Human Resources to endorse all such policies.

External review by 3 expert external committees:
- Global Access Advisory Committee (GAAC) - to provide independent and transparent strategic advice to GALVmed’s staff and Board on pro-poor access issues pertaining to the sustainable delivery of livestock vaccines, diagnostics and drugs in the developing world.
- Expert Scientific Advisory Committee (ESAC) - to provide independent and transparent strategic advice to GALVmed’s staff and Board on disease identification, disease epidemiology and on the selection and review of product development approaches for funding by GALVmed. ESAC should provide legitimacy and endorsement of the strategic R&D direction of GALVmed.
- Regional Advisory Committee – South Asia - to provide independent and transparent strategic advice to GALVmed’s staff on issues pertaining to the sustainable delivery of livestock vaccines, diagnostics and drugs in South Asia. b) Operational management and delivery
Directorate Group will ensure alignment of objectives and deliverables. The CEO and the senior management team are responsible for the day-to-day management of the entity and the delivery of the corporate plan, as agreed with the Board. A new Business Plan has been approved in March 2011 for the period of another 5 years.
The CEO has the responsibility for the day-to-day management of the organisation, including having appropriate delegated authority from the Board in relation to contracts, funding and project selection.
The CEO is the principal representative of the organisation and will be involved in activities such as fundraising, commercial lobbying, public relations and marketing. He/she will be a senior executive with a private sector animal health industry background and a clear understanding of the developing countries context. d)
GALVmed’s Intellectual property management
GALVmed has adopted a number of principles regarding ownership, rights distribution and knowledge dissemination for the management of intellectual property (IP). GALVmed evaluates and makes decision on all IP related issues on a case-by-case basis in line with the following overall principles with the objective of maximising public benefit:

GALVmed does not actively seek ownership of IP resulting from the conduct of such projects, unless such IP can be leveraged in downstream activities - such as in incentivizing downstream partners. Otherwise, GALVmed will instead relinquish title to resulting IP to partners who were involved in its generation but request for a non-exclusive license in return.

Additionally, GALVmed will not undertake responsibility for securing rights associated to such IP (patent protection, etc.) for results, unless it is reasonably determined that failing to secure such rights will ad versely affect GALVmed’s organisational mission.

GALVmed will negotiate for non-exclusive, worldwide rights to all pre-existing and resulting
IPs for the public benefit.

As part of its obligation to make information widely available and accessible, when possible
GALVmed will promote the dissemination of knowledge in IP in order to further its cause.
GALVmed will respect the interest of its partners and consult with them prior to publicly

disclosing any such knowledge. e) DFID
DFID’s Agricultural Team Deputy Programme Manager will be responsible for the day to day management of the programme. A Livelihoods Adviser in the team will provide technical advice drawing on experiences from other team members and cross-cutting advisers for An nual Review’s and other meetings as deemed necessary. DFID will attend the 6-monthly GALVmed Board meetings, and other meetings as and when required to discuss progress and any changes or revisions related to financial, technical, or workplan issues.
B. What are the risks and how these will be managed?
Table: Risks by outputs
Activity /Product Risks Impact if realised
H
Probability of realisation without &
(with
GALVmed mitigation)
L Output 1
Develop, register, facilitate production and availability of 5 -
7 veterinary vaccines, pharmaceutical or diagnostic products by the end of Phase 2 that impact on the needs of the poor livestock keepers
Developed assays are not suitable for field use/cannot be used in field
Output 2
Facilitate sustainable market development
& access programmes in a scalable way for a registerable portfolio of products.
Output 3
Advocate and create partnerships to achieve impact on animal health for poor farmers.
Markets do not respond, or if do not result in wider uptake
Impact not achieved due to poor advocacy and communications
M
L
L
M
Mitigation Measures
GALVmed chooses the best possible suppliers through open competition, subject to assessment by technical committees. Target Product
Profiles developed and in place, and subject to scrutiny by
Technical committees.
Technologies are evaluated on a go/no-go basis. GALVmed has effective processes and procedures in place for production agreements and mechanism in place to deliver appropriate technologies in a timely manner and suitable for field use. Appropriate back-up technologies identified if delivery of the primary technology is judged as not looking promising.
Last Mile distribution Models and Financial Models developed and in place.
Technical expertise available to implement supply chain studies.
Appropriate trainers identified to develop skills.
Processes in place for policy landscaping - appropriate expertise available and able to conduct policy landscaping studies. Policy sensitisation and training in place for participants.
Inventory of key policy makers.
Greater inclusion through workshops. Network of partners

Output 4
Consolidate
GALVmed as a high performing organisation
GALVmed not consolidated as a highperforming organisation, IP issues not resolved
M L established and broadened.
GALVmed Board has also appointed a deputy Chair and has strengthened its procedures to ensure that governance and management issues are identified and addressed promptly and appropriately.
IP - appropriate support identified. Organisational - availability of appropriately experienced and skilled staff. A capacity to deliver key functions of organization in place. M&E - relevant framework identified, relevant data in place for use.
Appropriately skilled external expertise /staff identified.
These assumptions have considered to the extent possible, but have not fully explored the full impact of natural (e.g. massive floods, earthquakes) and human made disasters (e.g. civil unrest, war) that could severely impact on GALVmed’s field delivery. In such cases, we will work with BMGF and
GALVmed to consider possible implications and mitigation measures and strategies as deemed appropriate.
C. What conditions apply (for financial aid only)?
Not applicable in this instance.
D. How will progress and results be monitored, measured and evaluated?
The programme logframe (Annex refers) has been designed by DFID and GALVmed. It is expected that the indicators and performance measurement framework will provide a sound basis for judging the success. The logframe also includes lessons learned from our earlier support. DFID will formally review progress on an annual basis and again in year 3 as part of the independent evaluation process.
Monitoring
DFID requires GALVmed to have in place a clear and credible work plan with effective project management arrangements and related M&E framework in place to help track both technical and management performance.
GALVmed ’s M&E Strategy (see also section D in Appraisal Case) sets out data requirements, potential data sources and how the data will be obtained and monitored at the start of the project (baseline), at various stages of each project (milestones) and at the end of the project (target) to help assess the trajectory of outputs through to outcome (Purpose) and Impact (Goal). Sex disaggregated data will be generated and analysed as par t of the process of monitoring impact on women’s assets and livelihoods and wider benefits to poor households. Specific gender related outputs will also be produced.
DFID and BMGF will attend the GALVmed Board meetings and will review organisational and technical progress through regular reports and annually through the normal programme management cycle.
Evaluation
DFID anticipates initiating an external independent evaluation of GALVmed in year 3 of our support.

Logframe
Quest No of logframe for this intervention: 3399096