BUSINESS CASE: UK Support to Polio Eradication 2013 - 2019 Acronyms AFP Acute Flaccid Paralysis BMGF Bill and Melinda Gates Foundation bOPV Bivalent Oral Polio Vaccine CDC Centers for Disease Control cVDPV Circulating vaccine-derived poliovirus GAVI Global Alliance on Vaccines and Immunisation GPEI Global Polio Eradication Initiative IMB Independent Monitoring Board IPV Inactivated Polio Vaccine MRI Measles and Rubella Initiative mOPV Monovalent Oral Polio Vaccine OPV Oral Polio Vaccine RI Routine Immunisation SAGE Strategic Advisory Group of Experts on Immunisation SIA Supplementary Immunisation Activity SIAD Supplementary Immunisation Activity Days OPV Trivalent Oral Polio Vaccine UNICEF United Nations Children’s Fund VAPP Vaccine-associated Paralytic Polio VDPV Vaccine-derived poliovirus WHO World Health Organisation WHA World Health Assembly WPV Wild Poliovirus 1 Definitions Polio Control: The reduction of disease incidence, prevalence, morbidity or mortality to a locally acceptable level as a result of deliberate efforts; continued intervention measures are required to maintain the reduction. Polio Elimination: Reduction to zero of the incidence of disease in a defined geographical area as a result of deliberate efforts; continued intervention measures are required. Polio Eradication: Permanent reduction to zero of the worldwide incidence of infection as a result of deliberate efforts; intervention measures are no longer needed. Polio Sanctuary: very small geographic areas (e.g. local government areas within Nigeria) where the polio virus persists and polio cases are concentrated. 2 Business Case and Intervention Summary Intervention Summary: UK Support to Polio Eradication What support will the UK provide? The UK will provide up to £300 million over six years1 (UK financial years 2013/14 - 2018/19) to support global polio eradication. This support will contribute to the interruption of polio transmission in the remaining endemic countries (Pakistan, Afghanistan and Nigeria), for outbreaks to be controlled and for necessary services to be established that will ensure eradication of polio in the course of the next six years. The UK’s support will enable the full vaccination of more than 360 million children. Why is UK support required? Polio cases have decreased by over 99% since the launch of the Global Polio Eradication Initiative (GPEI) in 1988, from 350,000 to 1,352 by 2010, 650 cases in 2011, and 223 in 2012 and 54 by June this year. The UK has contributed significantly to this progress, has been a consistent supporter of this global effort since its launch, and is the second largest public sector donor to the initiative (behind the US). The GPEI has already prevented polio paralysis in more than 8 million children. GPEI is the world’s largest public health initiative. In 2012, GPEI administered more than 2.032 billion doses of oral polio vaccine (OPV) to more than 429 million children (and adults in some places) during 210 polio vaccination campaigns in 45 countries. India, long considered one of the most challenging countries in which to eradicate polio, successfully stopped polio transmission in 2011, leaving Nigeria, Pakistan and Afghanistan as the only countries still to do so. Urgent efforts have been underway to ensure that vaccination coverage is improved to the levels needed to stop poliovirus transmission. Children in polio-free areas of Africa and Asia remain particularly at risk from poliovirus importations from the remaining endemic areas and recognising this, the World Health Assembly (WHA) in May 2012 declared the completion of polio eradication a programmatic emergency. The GPEI has developed a longer term 2013-2018 Polio Eradication and Endgame Strategic Plan to achieve eradication. Ambitious and untested in places, this sets out a costed Strategy and provides options for the “Legacy” support that polio infrastructure and investments can provide for other public health initiatives, and for health systems and routine immunisation services. The GPEI estimates that the budget needed to complete eradication and certification by 2018 is approximately $5.5 billion, with continuing modest costs2 for up to 7 years post eradication. The Abu Dhabi Vaccine Summit in April 2013 raised $4billion in pledges. This gives GPEI a clear mandate (and vote of confidence) to plan ahead systematically, including vaccine procurement where it will work in strategic partnership with the GAVI Alliance. It challenges them to deliver the results to underpin the advocacy necessary to attract additional funding to close the balance over time. Funding shortfalls result in vaccination campaign cutbacks or cancellations, leaving children under1 2 This amount is about 8.4%of the total $5.5 billion requirement over the period Additional costs from 2019 to 2025 are roughly $800 million, so nearly $115 million per year on average 3 immunised and at risk. Polio is susceptible to epidemics, for example, 460 cases and 441 cases were reported in Tajikistan and the Republic of Congo respectively over just a period of few months in 2010, with large fatalities among adults. Between May to July 2013, the Horn of Africa outbreak has led to over eighty cases. Without adequate and consistent longer-term financing for 2013-18, there is every possibility that countries will slide back resulting in large outbreaks of polio, disability and death. Polio continues to be transmitted mainly in poor, remote and conflict-affected areas such as the border region between Afghanistan and Pakistan, and several of the northern Nigerian states, where public services generally, including health, social welfare and education, are in short supply and of poor quality. Communities feel ambivalent about polio vaccination because they see few cases, and it is often the only health service provided, and sometimes a wider distrust of the motives for polio vaccination. The end result has been an increase in refusals as well as violence against health workers. GPEI recognise that polio eradication is not solely a health problem and a “business as usual” approach in conflict-affected areas will not allow vaccination to happen at the level needed to stop transmission. In May 2012, the Independent Monitoring Board (IMB) of the Global Polio Eradication Initiative chaired by Sir Liam Donaldson( former Chief Medical Officer for England) noted that, “The sense of emergency has heightened, real progress has been made…In the last four months, there have been fewer cases, in fewer districts of fewer countries than at any time in history.” But “the Initiative is being severely jeopardised by a major funding shortfall; this is an extreme and unacceptable risk.” However, funding is not the only challenge. As a result of the IMB’s influence reinforcing some donor concerns, in recent years, attention has shifted from technical and epidemiological challenges to the governance and ‘people factors’ that are critical to programme effectiveness, for example political commitment, understanding alliances with local and religious leaders and human resource management. Furthermore, the IMB report of November 2012 drew attention to endemic country ownership, accountability and leadership as critical factors required to complete eradication goals,3 which India’s success demonstrated. Based on this lesson, DFID’s funding is designed to be flexible so that it supports not only GPEI but also targeted initiatives in Nigeria and Pakistan to embed polio programming within a wider response to meeting community needs. The UK’s leadership and multi-year financial support of this longer-term strategy continues not only to safeguard and improve the efficiency of supply chain security and effective delivery but also to secure other donors’ and governments’ contributions, and to ensure that polio investment is made in ways that benefit wider public health, community development and conflict resolution. This more comprehensive approach is expressed in two ways: through UK support direct to GPEI that also draws on our experience with matched funding, and a separate budget line to respond in innovative ways to challenges to achieving the eradication goal. What are the expected results? By 2018 all countries will have interrupted transmission of all the three types of wild polio virus resulting in the historic elimination of polio. Post certification, it will make polio only the second human disease after smallpox to be eradicated. Access to overall health services will be improved in endemic areas, and routine immunisation services strengthened, resulting in health gains beyond polio. Expected non-health related benefits include community empowerment and contributions towards conflict resolution. The cost per DALY saved is estimated at US $210 in low income countries. At this level of value for money, DFID’s £300m (US $450 m) contribution towards eradication translates to averting 2.14 m DALYs over the period 2013 – 2018. 3 Polio’s Last Stand, Report of the Independent Monitoring Board of the Global Polio Eradication Initiative, November 2012 4 The results will also include: The vaccination of more than 360 million children The interruption of polio transmission The establishment of legacy planning to ensure eradication is sustained Routine immunisation coverage rates of more than 80% in all currently endemic countries. Improved surveillance and global monitoring Elimination of vaccine derived polio Transition to inactivated polio vaccines with the assistance of GAVI. 5 Business Case Strategic Case A. Context and need for a DFID intervention Technical 1. Poliomyelitis is an acute illness that follows invasion through the gastro intestinal tract by one of the three serotypes of polio virus (serotypes 1, 2 and 3). The virus replicates in the gut and has a high affinity for nervous tissue.4 2. Polio is spread through person-to-person contact, via faeces or pharyngeal secretions of an infected person. The wild poliovirus enters the body of the child through the mouth due to food or drink contaminated by faeces, and then multiplies in the intestine. It is then shed into the environment through the faeces where it can spread rapidly through a community, especially in situations of poor hygiene and sanitation.5 The incubation period ranges from three to 21 days. Polio virus replicates for longer periods and it can be excreted for three to six weeks in faeces and two weeks in saliva.6 Cases are most infectious immediately before, and one to two weeks after the onset of paralytic disease.7 Symptoms and Effects of Polio 3. Most infected people (90%) have no, or very mild, symptoms and the infection usually goes unrecognised. In others, initial symptoms include fever, fatigue, headache, vomiting, stiffness in the neck and pain in the limbs. Most carriers of the poliovirus can spread the infection “silently” to thousands of others before the first case of polio paralysis emerges. 4. Among those infected, only one in 200 infections leads to irreversible paralysis, usually in the legs. This is caused by the virus invading the central nervous system. As it multiplies, the virus destroys the nerve cells that activate muscles, which then makes the limb become floppy and lifeless, a condition known as acute flaccid paralysis (AFP). 5. In some cases, there is more extensive paralysis, involving the trunk and muscles of the thorax and abdomen, and this can result in quadriplegia. In the most severe cases, poliovirus attacks the nerve cells of the brain stem, reducing breathing capacity and causing difficulty in swallowing and speaking. Among those paralysed, 5% to 10% die when their breathing muscles become immobilised. Such severe forms of paralysis were reported in the outbreaks in 2010 and 2011 in the Republic of Congo, Tajikistan and China. 8 Response 6. There is no cure for polio, but there are safe and effective vaccines. Polio can strike at any age, but it mainly affects children under five years old. If a sufficient number of children are fully immunised against polio, the virus is unable to find susceptible children to infect, and dies out. The strategy to eradicate polio is therefore based on 4 Sutter RW, Cochi S and Melnick JL (2004) Live attenuated polio virus vaccines. In: Plotkin SA and Orenstein WA (eds) Vaccines, 4th edition. Philadelphia: WB Saunders Company. 5 http://www.polioeradication.org/Polioandprevention.aspx Gelfand HM, LeBlanc DR, Fox JP and Conwell DP (1957) Studies on the development of natural immunity to poliomyelitis in Louisiana II. Description and analysis of episodes of infection observed in study households. Am J Hyg 65: 367– 85. 7 Sutter RW, Cochi S and Melnick JL (2004) Live attenuated polio virus vaccines. In: Plotkin SA and Orenstein WA (eds) Vaccines, 4th edition. Philadelphia: WB Saunders Company. 8 http://www.polioeradication.org/Polioandprevention.aspx 6 preventing infection by immunising every child until transmission stops and the world is polio-free.9 7. The choice of vaccine10 is affected by risk benefit ratios given differing epidemiological profiles of countries. When polio infection is endemic, the paralytic disease is caused by naturally occurring polio virus – ‘wild virus’. A second, rarer cause of paralytic polio is vaccine-associated paralytic polio (VAPP), which can occur when the live attenuated oral polio vaccine (OPV) virus reverts to a virulent form. Once wild viruses have been eliminated, continued use of OPV poses the risk of continued VAPP cases.11 At this stage the injectable Inactivated polio vaccine (IPV) – which does not cause VAPPs – is introduced into a country’s routine immunisation services. A country then delivers 2 doses of OPV and one dose of IPV through routine immunisation, until such a time as the global risk of VAPP disappears and the elimination phase is complete.12 The plan is to stop the use of OPV by 2019 and to continue IPV as part of the vaccination schedule. Some countries might decide to discontinue IPV around 2025, depending on their assessment of risks, and on financial and programmatic considerations. History of polio eradication 8. The goal to eradicate polio globally was adopted through a resolution at the World Health Assembly in 1988. The Global Polio Eradication Initiative (GPEI) – a publicprivate partnership launched shortly after provides support to national governments to achieve this goal. Its four original founder members - known as spearheading partners - are WHO, UNICEF, Rotary International and the US Centers for Disease Control. The Bill and Melinda Gates Foundation, and Mr Gates personally, have become increasingly prominent and influential GPEI backers. The UK is a long-standing supporter, contributing about 10% of the total $9 billion spent on polio eradication through the global eradication initiative since 1988. Our last business case provided £166 million over 5 years and ended in 2012. 9. Since its launch, GPEI has immunised more than 2.5 billion children thanks to the cooperation of more than 200 countries and territories, and 20 million volunteers, backed by an international investment of more than US$ 9 billion. 10. When all countries in a WHO Region record zero cases of polio for 3 consecutive years, the region is certified polio-free. WHO’s PAHO (Americas) Region was certified polio free in 1994; the Western Pacific Region in 2000; and the European Region in 2002. If India remains polio-free for 3 years, then the WHO South East Asia Region will be certified polio-free in 2014. Disease burden 11. Polio cases have decreased by over 99% since 1988, from an estimated 350,000 cases to 650 cases in 2011, and 223 cases in 2012. Only three countries (Afghanistan, Nigeria and Pakistan) remain polio-endemic, down from more than 125 countries in 9 http://www.polioeradication.org/Polioandprevention.aspx 10 Two basic categories of vaccine exist against polio – OPV and IPV: 1) Oral polio vaccines (OPV) or Sabin vaccines contain live, attenuated (weakened) poliovirus, of which there are three types of OPV: (i) trivalent oral polio vaccine (tOPV), contains a mixture of the live, attenuated (weakened) poliovirus strains of all three wild poliovirus types (types 1, 2, 3). Note: Type 2 poliovirus has been eliminated in the wild, with its last detection in 1999.(ii) Monovalent oral polio vaccines (mOPV) contain the live, attenuated poliovirus strains of either type 1 (mOPV1) or type 3 (mOPV3) poliovirus only. Unlike OPV, mOPV does not contain the other two types of poliovirus and only protects against one type (either 1 or 3) of poliovirus, depending on the formulation and (iii) Bivalent oral polio vaccine (bOPV) contains two types of live, attenuated poliovirus strains (type 1 and 3), thus targeting the two remaining types of wild poliovirus, simultaneously. 2) Inactivated polio vaccine (IPV), a.k.a. the Salk vaccine, contains the inactivated (killed) poliovirus strains of all three poliovirus types and is a non-oral vaccine, administered via intramuscular injection. 11 UK Department of Health, “Immunisation Against Infectious Disease”, Chapter 26 Poliomyelitis 12 UK Department of Health, “Immunisation Against Infectious Disease”, Chapter 26 Poliomyelitis 7 1988. While the decline in the global incidence was steep in the first dozen years of the Initiative (Figure 1), the trend slowed in the last decade (Figure 2)13 in the face of the significant challenges in India, Nigeria, Pakistan and Afghanistan, and also the international spread of polio from India and Nigeria that caused polio outbreaks in more than 40 countries in Africa and Asia. Figure 1: Progress towards eradication since start of GPEI 13 Data source for Figures 1 and 2: GPEI http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx 8 Figure 2: Recent challenges decelerates progress Economic Impact and Benefits of Polio Eradication 12. Eradication is taking longer and is more expensive than earlier expected. Even so, achieving polio eradication remains economically justified given that the alternative (i.e., ‘control’) would lead to a very substantial increase in disease burden, unless expenditures remain extremely high in perpetuity. Pursuing a strategy of control may be less expensive than eradication in the next few years, but the cumulative costs of this approach over time (operational costs, but also productivity losses and treatment costs) would quickly overtake the costs of eradication. 13. As with any eradication effort, the cost required to avert each case increases as case numbers diminish; much of the value of eradication comes from the perpetuity gains from eliminating the long term expenditure and disease burden. The most robust and recent analysis available14 calculated the total (incremental) benefits of global polio eradication of approximately US$40 and $50 billion between 1988 and 2035 when compared to the cost and results expected from routine vaccination. Polio eradication costs more than routine immunisation but it results in much more benefit. This analysis uses relatively conservative assumptions, excluding benefits accruing to other disease efforts impacted by GPEI and including only benefits in the 104 countries directly impacted by the GPEI15. The poorest countries benefit the most from completing polio eradication due to the huge incremental number of paralytic poliomyelitis cases prevented. Many poor and fragile countries have successfully eliminated polio. India has not had a polio case since January 2011 and this was thought to be the most challenging country at one point. 14. The analysis considers whether GPEI will deliver a net benefit overall, assuming that it 14 Ibid. 15 The analysis is assumes there would be no impact on other countries from polio eradication. 9 ultimately succeeds. Although it assumes that 2012 would have been the year when wild poliovirus would be interrupted, sensitivity analysis revealed that the net benefits were not significantly affected by a delay to 2015, which seems the more likely scenario now. The analysis tests several assumptions including: the long-term epidemiology of the disease in the alternative scenarios and for other inputs; posteradication risks, such as the emergence of outbreaks, which are assumed to be controlled successfully; ratio of internal to external contributions to GPEI; and delay in achieving eradication. The paper does not present the findings from all of these scenarios however the results appear to be robust to changes in these assumptions16. 15. A 2013 BMGF-funded briefing17, drawing on the earlier published analysis, found eradication remains the most cost-effective approach. Even with the additional $5.5 billion invested, implementing the eradication plan will deliver an around $25 billion in additional net benefit over 20 years. This is net positive in relation to the $5.5 billion required by GPEI to finish the job and even when compared to the fuller costs of $10.3 billion 2013-2018 which include not only GPEI’s $5.5 bn but also plus India’s eradication spend ($1.1 bn), routine immunisation ($1.2 bn), and in-country non-cash costs ($2.5 bn). The analysis concluded that all eradication scenarios are more cost effective than alternatives. It also leads to greater returns – eradication benefits would be up to $45 billion for 30 years from 2013, which does not include cost savings from outbreaks in high and middle countries. Source: “Economic Case for Eradicating Polio”18 Success eradicating polio in India 16. India has not recorded any wild polio cases since January 2011. This huge 16 Centre for Reviews and Dissemination, University of York, http://www.crd.york.ac.uk/crdweb/ShowRecord.asp?LinkFrom=OAI&ID=22011000039 17 “Economic Case for Eradicating Polio”, http://www.polioeradication.org/Portals/0/Document/Resources/StrategyWork/EconomicCase.pdf. 18 ibid 10 achievement gave new impetus to the global eradication effort, since it was considered one of the toughest places to eradicate polio. The enormous challenges included the sheer size (more than 172 million children under five years of age to be vaccinated) and diversity of the population combined with environmental, behavioural and other factors. This achievement benefits not only the Indian population, but also the rest of the world. Until recently, India was a leading exporter of wild poliovirus, reaching as far away as Angola, the Democratic Republic of the Congo and Tajikistan, in addition to frequently re-infecting Nepal and Bangladesh. The key elements of India’s success include: Strong commitment and leadership at Federal government level, translated into close engagement with the concerned state governments, and close oversight of the implementation of the strategic plan at every level of governance; Fully implementing intense and focused polio eradication activities which include between 8-10 different large scale activities per year, and small mop-up campaigns; The deployment of large numbers of experienced personnel in targeted remote communities; The deployment of a massive network of trained staff to plan and conduct comprehensive social mobilisation activities; Using the polio infrastructure to improve routine immunisation in Bihar; Fostering a culture of continuous innovation, technical (vaccine-related) as well as operational, to persevere through numerous obstacles, reach missed children, and drive immunity levels above the interruption threshold. Vaccine innovations have included testing (immunogenicity studies) and deployment of monovalent and bivalent vaccines and evaluation of their impact through targeted sero-prevalence studies. The Indian programme also implemented a series of operational innovations, some of which represented major shifts in vaccine delivery strategies.19 This included an 'underserved' strategy, Supplementary Immunisation Activity Days (SIADs), universal finger-marking, migrant and transit strategies, and independent monitoring. Holding local governments and officials responsible for the quality of vaccination campaigns, including an emphasis on good quality data and ensuring that every child was reached and vaccinated - coverage rates of up to 99% were achieved in the key states of Uttar Pradesh and Bihar- and confirmation by rigorous monitoring and serologic surveys; Consistent domestic funding for polio eradication activities by the Government of India – 75% (US$1.5 billion out of a total of US$2 billion) of expenditure on polio since 1985 has come from domestic funding). Endgame Strategic Plan 17. The GPEI has achieved enormous success by globally eradicating wild poliovirus type 2, eliminating type 1 and 3 transmission in all but a few remaining endemic areas, and reducing the overall incidence of paralytic poliomyelitis by over 99%. Figure 3: Remaining polio endemicity 19 For further details, see: http://www.polioeradication.org/Portals/0/Document/Resources/StrategyWork/EAP/EAP_annex1.pdf 11 Strategic Plan 18. The 2013 World Health Assembly (WHA) endorsed the GPEI Eradication and Endgame Strategic Plan 2013-2018. The Plan covers a six year period during which identifies but does not guarantee several crucial milestones in eradication. These include the end of polio transmission, certification, a switch to critical on-going surveillance arrangements, and introducing Inactivated Polio Vaccine (IPV) into routine immunisation services globally up to approximately 2025. The Plan expects to achieve key programmatic milestones according to the following timeline: Table 1: Key milestones20 DATE End-2014 During 2015/6 End-2018 During 2019 MILESTONE Interruption of transmission/Last wild poliovirus case Withdrawal of Oral Polio Vaccine 2 (OPV2) Global Wild Polio Virus (GWP) Certification Bivalent Oral Polio Vaccine (bOPV) Cessation 19. The first programmatic milestone is the last wild poliovirus case, projected by end2014. There is no guarantee that this will be achieved, in view of the risks beyond GPEI’s control, but the Plan puts mitigating actions in place. With the last wild poliovirus case, the Global Certification Commission will begin its work, with the regional bodies providing regional certification documentation. The global certification process is timetabled to take until end-2018. Each of these objectives, with accompanying activities, and milestones fits together into the overall strategy, illustrated in Figure 421. 20 Polio Eradication and Endgame Strategic Plan, May 2013Dec 7 2012 21 Polio Eradication and Endgame Strategic Plan, May 2-013Dec 7 2012 12 Figure 4: Overview of Eradication and Endgame Strategic Plan 20. The current Polio Endgame Strategic Plan, Legacy Options and Financial Requirements22 forecasts that US $5.5 billion is necessary to implement this plan. This does not include OPV and IPV vaccine costs after 2018, which will be sustained through national funding for routine immunisation subsidised by GAVI as required. Current challenges to reaching eradication 21. An important hurdle is financial and closely related to this, securing and maintaining the necessary degree of political will and commitment from both endemic country governments and the global community including donors. The eradication programme has encountered significant problems closing the annual budget requirement since 2000, and accumulated financial costs at an increasing rate associated with delays and increased intensity of efforts. Until late 2012 there were accumulating concerns about the strategy, signs of donor fatigue, limited financial contributions from endemic and reinfected countries, and a push to diversify the donor base while maintaining funds from historic donors. Bill Gates co-hosted a Global Vaccine Summit 24-25 April 2013, with the Crown Prince of Abu Dhabi and the United Nations Secretary General, during World Immunisation Week. This had the objective of raising funds for polio eradication on the back of a credible Strategic Plan and raised about $4 billion against the target of $5.5 billion (over 70% of the requirement). This vote of confidence for the Global Polio Eradication Initiative’s (GPEI) new six year Strategic Plan, which the UK played an active role in shaping, provides GPEI the clear mandate to plan ahead, including the procurement of vaccine, and the introduction of IPV. 22. The Plan challenges GPEI to demonstrate that the Strategy is credible. Its negotiation proved a lengthy process, largely due to stakeholder concerns (including the IMB’s) around GPEI’s operational effectiveness and organisational structure, particularly noting the considerable expansion in the Plan’s scope. The UK and donor partners are satisfied that the Plan’s governance structure (involving independent oversight of each Objective by a different entity) and a revitalised role for the country Technical Advisory Groups (TAGs) provide a sound basis on which to proceed. This ambitious achievement will now be tested through implementation, and monitored through the 22 Working paper draft circulated December 2012 13 Plan’s oversight arrangements. Jointly,donors will monitor the effectiveness of these revised governance arrangements, and consider steps including an institutional review if GPEI falls short. The Bill and Melinda Gates Foundation committed $1.8 billion, or one-third of the total needed. Canada, Norway and Germany made key bilateral pledges in response to the Strategy’s approach. The UK pledged up to £300 million. The United States and Rotary International are expected to come through with additional resources. The list of new donor pledges was wide ranging and included Nigeria, one of the three remaining endemic countries. The pledges announced in Abu Dhabi (Box 1) will enable over a billion children to be fully vaccinated. Box 1: Abu Dhabi Global Vaccine Summit Pledges Pledges made to GPEI at the Global Vaccine Summit Bill and Melinda Gates Foundation United Kingdom Norway Canada Islamic Development Bank/Government of Pakistan Germany Crown Prince of Abu Dhabi Bloomberg Philanthropies Carlos Sim Foundation United States Rotary International UNICEF World Bank European Commission Others (incl Nigeria) Total Amount (in US $ million)23 $1,800 $457 $252.45 $243.53 $227 $151.7 $120 $100 $100 $90.6 $76.81 $64.5 $60 $50 $248.26 $4.042 billion 23. A second challenge relates to the transition from OPV to IPV and the cessation of the use of OPV. In May 2008, in line with guidance from WHO’s Scientific Advisory Group of Experts on Immunisation (SAGE), the WHA endorsed the principle of OPV cessation, due to the risks posed by vaccine-derived polioviruses. Thus, posteradication risk management planning has now shifted to assume that IPV will gradually replace OPV in the post-eradication period.24 However, there remains some uncertainty surrounding the exact policies countries will pursue after they stop using OPV. A major section of the Strategic Plan addresses this challenge. GPEI plans to secure a stockpile of mOPV and response capacity, facilitate global access to bOPV for RI programmes, secure affordable IPV and introduce IPV globally through routine immunisation, strengthen routine immunisation to improve IPV coverage, and withdraw OPV2. This will require a close strategic alliance with GAVI and a lead role for GAVI in working with countries to introduce IPV into routine immunisation services. 24. Another serious challenge for GPEI relates to links with routine immunisation and other health services, and criticism that the polio programme diverts scarce human resources from basic health services. This challenge is particularly important in the remaining endemic countries which, in an effort to step up their polio performance, 23 24 http://www.polioeradication.org/Financing.aspx See Resolution WHA 6.1.1: “Poliomyelitis: mechanism for management of potential risks to eradication” 14 have prioritised polio over most other preventative health services in some target populations/ geographical areas. In some countries GPEI has acted as a separate vertical initiative but the move from OPV to IPV provides the opportunity to accelerate its integration and align it more within routine immunisation. This will improve efficiency by using GPEI’s infrastructure and tools to best effect. Polio workers reach places not served by other services, for example its microplanning, work with hard to access groups e.g nomads.In response, GPEI has increasingly focused on bringing benefits to other health programmes. In the past, these efforts were largely opportunistic. But the new Plan set out a much stronger approach to strengthening immunisation systems and legacy planning as integral components, and these contributions will generate additional economic benefits. In particular, GPEI has set targets and milestones to increase routine immunisation coverage in the highest-risk areas of 10 countries by 10% each year, from 2015 to 2018. GPEI will collaborate with national authorities, GAVI, and partners in developing annual plans for routine immunisation, drawing on the recent experience of GPEI in Bihar, India which showed the power of this approach. Routine, country based immunisation programmes are vital to ensuring that polio eradication can be maintained, particularly with the introduction of IPV. We recognised the need to make national health systems capacity a priority when providing additional support over 2011-2012.The Bihar polio program not only achieved elimination but simultaneously contributed to increasing RI coverage from 19% in 2005 to 67% in 2010. GPEI has also now set a target that by the end of 2014 its workers in 10 focus countries spend at least 50% of their time on activities intended to strengthen RI coverage. This includes activities such as improving program management, strengthening micro-planning, engaging communities, and monitoring of program performance. 25. At country level, the problems faced in interrupting transmission in northern Nigeria and parts of Pakistan include: an insufficient identification and coverage of children; sub-optimal monitoring and surveillance; erosion of routine immunisation systems, fundamental to the eradication of polio, partly because attention has been diverted to polio campaigns; negative side effects of political commitment on community acceptability of polio; on-going community fears about sterility; politicisation and coercion, all of which perpetuate/ build resistance; and safety concerns for polio workers following the recent attacks. Both countries have challenges reaching every child with geographical areas that are completely inaccessible, and populations that are highly mobile and so hard to serve because of intermittent or long-term conflict and insecurity. Success in this end game phase will require not only adequate funding and effective technical management but also addressing the underlying social and political reasons why groups are sceptical about, or hostile to, government polio vaccination drives; this is likely to involve improved provision for public health interventions and other services people actually feel they need. 26. The GPEI and the IMB have evaluated the major obstacles in detail by country25 and DFID country teams have clear views as well: In Nigeria, 95% of cases arise in eight endemic northern states: Borno, Jigawa, Kano, Katsina, Kebbi, Sokoto, Yobe and Zamfara, where security concerns continue to hamper the polio eradication effort.26 The most critical barriers include management prioritisation, in particular the highly variable importance ascribed to polio by different authorities including at the local government level, low routine immunisation, funding 25 http://www.polioeradication.org/Resourcelibrary/Evaluations.aspx 26 Polio Global Eradication Initiative (31 October 2012). "Wild Polio Virus infected Districts". Polio Global Eradication Initiative. http://www.polioeradication.org/Dataandmonitoring/Poliothisweek/Polioinfecteddistricts.aspx/. Retrieved 8 November 2012. 15 limitations, community perceptions of vaccine safety, inadequate mobilisation of community groups, and issues with the cold chain which have played a role.27 Some communities continue to be missed because of poor organisation of the polio eradication campaign, including inadequate communications about campaigns. Leadership from some multilateral organisations is being strengthened. Incentive structures for those doing the difficult work of polio eradication on the ground need to be more closely linked to results and success. A further problem is the politicisation of polio; success in eradication has become associated with the current Federal Government which overshadows and distorts the public health benefits, particularly in the run up to national elections. Over 60% of cases in Pakistan are in known high risk districts in Balochistan and the Federally Administered Tribal Areas.28 In 2012, Pakistan made substantive and fundamental changes to its strategic and operational approaches, most crucially in the level, intensity and structure of government oversight, programme operations management, and performance accountability. There are remaining challenges but more research is needed to pinpoint exactly what can be done. It is clear that several factors are at play including, in some places, a lack of trust in vaccinators and other health workers, exacerbated by the fake Hepatitis B vaccination campaign in Abbottabad.29 The Taliban or others have in places killed or threatened vaccinators and banned or spoken against polio campaigns. Despite good progress in 2012 in the remaining sanctuaries, the December 2012 episodes of violence against polio vaccinators, illustrate the formidable challenges faced by the programme in Pakistan. Since the recent federal election, a new central ministry of health has been reestablished. The new government has expressed a commitment to polio eradication but it is too soon to assess their performance or the degree of political will they will apply. In Afghanistan, polio is primarily restricted to the traditionally endemic Southern region and Farah province in Western region, where the significant operational challenge is to reach all children. There has been good progress, especially with regard to innovation of using female vaccinators to improve access. In 2013, most cases of polio confirmed in Afghanistan have been imported from Pakistan. Recent gains could be at risk after the 2014 elections with the possibility of political turbulence and increased population movement. 27. The focus of cases shifted in 2012 so that Nigeria not only has the highest number, but due to population mobility, also poses a great risk of reinfecting neighbouring countries. In 2011, polioviruses originating in Nigeria were detected in five countries in west and central Africa.30 The combination of underdeveloped health systems and low routine vaccine coverage puts countries like Angola, Chad, the Horn of Africa and South Sudan at risk of polio spread from remaining endemic countries. 27 http://www.polioeradication.org/Resourcelibrary/Evaluations.aspx 28 GPEI Annual Report 2011, page 22 29 CIA organised fake vaccination drive to get Osama bin Laden's family DNA http://www.guardian.co.uk/world/2011/jul/11/cia-fake-vaccinations-osama-bin-ladens-dna 30 GPEI Annual Report 2011, page 19 16 Table 2: Polio cases, endemic countries 2011 and 2012 Countries Pakistan Afghanistan Nigeria 2011 cases in endemic countries (total, all types) 198 80 62 2012 cases in endemic countries (total, all types)31 58 37 122 28. Outbreaks are not unusual and characterise the trickiness of the polio challenge. There was an outbreak in Chad and Niger in 2012. The outbreak in the Horn of Africa has flared up since May 2013. As of 2October 2013, a total of 196 Wild Polio Virus type 1 (WPV1) cases have been identified (175 in Somalia, 14 in Kenya,4 in Ethiopia and 3 in South Sudan). Millions of children aged 15 years and under are being immunised across several countries in two rapid campaigns. Outbreaks divert resources and attention. Why DFID should continue to intervene 29. UK leadership, especially within the G8 and GPEI, has been instrumental in maintaining commitments from other G8 members (particularly Germany). The UK’s matching challenge fund mechanism in 2011 and 2012 provided incentives for other donors, both public and private sector, to contribute to the global eradication effort. Key reasons to maintain support at this stage are: a) b) c) d) e) f) g) Children in all polio-free countries continue to be at grave risk of importations from the endemic countries, and increasingly these outbreaks are becoming more deadly and are affecting adult populations. The success of stopping polio transmission in India removes doubt over the technical feasibility of polio eradication, if the strategies are fully implemented; In 2012 the global effort witnessed the lowest number of polio cases in the least number of countries, and in the least number of districts – an opportunity to be seized. Failure to fully finance and implement the 2013-2018 Strategic Plan and legacy plans will jeopardise the 25 years of investment of US $9 billion in eradication efforts. Failing to finish polio eradication will result in the world, within a decade, reporting up to 200,000 polio cases per year, primarily in (but not limited to) the poorest countries. A key emphasis of the Strategic Plan is to strengthen routine immunisation. DFID recognises the potential this offers to improve coverage for other vaccine preventable diseases, and will continue to play a leadership role in this area. DFID’s large programme in Nigeria (where over 50% of the remaining polio disease burden remains) can influence policy and programming in a way that leverages polio to the advantage of improved public health and health services overall. 31 http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx. Accessed May 15 2013 17 B. Impact and Outcome that we expect to achieve 30. We expect to achieve the historical eradication of polio and secure the gains through post eradication surveillance and containment of wild polioviruses, vaccination using inactivated polio vaccines, and support for other critical public health initiatives, including strengthening routine immunisation. The best estimates suggest incremental net benefits of global polio eradication between the period of 1988 through 2035 of up to $50 billion when compared to routine vaccination.32 32 Tebbens, R., Pallansch, M., Cochi, S., Wassilak, S., Linkins, J., Sutter, R., Aylward, B., Thompson, K. Economic analysis of the global polio eradication initiative. Vaccine 29 (2011) 334-343. 18 Appraisal Case A. What are the feasible options that address the need set out in the Strategic case? Options for DFID support The options reviewed for DFID support include: Option 1 1. Stop funding GPEI and revert to polio control through routine immunisation. Option 2 2. Provide £300 million in funding direct to GPEI 2013/14 to 2018/19. Option 3 3. Deliver £300 million between 2013/14 to 2018/19 through both GPEI and direct bilateral channels to address the remaining obstacles to eradication. Options 2 and 3 are analysed with respect to their ability to meet funding needs, ability to leverage in funding from other donors and ability to encourage improved performance towards the goal of eradication. Several components/ funding channels under Option 3 are evaluated. 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 Op tio n 1 2 3 Evidence rating Medium Medium Medium Each option should be evaluated for cost effectiveness, value for money, and ability to respond to the identified obstacles to eradication. 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. Op tio n 1 2 3 Climate change and environment risks and impacts, Category (A, B, C, D) B D D/C Climate change and environment opportunities, Category (A, B, C, D) B D D/C 31. The counterfactual (Option 1) would have higher environmental risks since it provides no incentive to tackle water and sanitation in order to support polio eradication and lower opportunities. The remaining two options have lower climate and environment risks and opportunities. Direct environmental risks come from the disposal of waste associated with the vaccination campaigns. This is primarily from the storage of the vaccine in plastic ampoules and the Styrofoam cold boxes that need to be disposed of during campaigns. This is relatively easy to manage by ensuring basic waste management guidelines are followed requiring 19 vaccination teams to bring waste back to a central waste disposal facility. There are no issues with disposal of syringes because the vaccine is administered orally, but this will change with the introduction of IPV. GPEI/ GAVI will extend their standard protocols to include polio syringe disposal. 32. Polio is a classic faecal-oral route disease, so interventions to improve sanitation, hygiene and water supply reduce incidence by interrupting transmission routes. The transmission of poliovirus is most common in communities with poor water and sanitation. A failure to ensure adequate drinking water supply and sanitation is likely to result in a residual risk of re-emergence of polio until eradication is achieved. 33. Whilst eradication relies on vaccination it is important that an integrated approach is taken. Improved sanitation, drinking water and hygiene should also be promoted as a supporting set of interventions. Without such complementary intervention achieving eradication may continue to be difficult. 34. There are also risks associated with the excretion and circulation of vaccine derived polio virus (VDPV) into the environment. In the Morbidity and Mortality Weekly Report of September 21 2012, CDC identified a number of outbreaks of VDPV where person-person contact is implicated, probably as a consequence of poor hand washing and likely to also result in communities with inadequate sanitation. Outbreaks in DRC and Somalia were live and continuing and new outbreaks were detected in Mozambique and Yemen. Genetic evidence indicated renewed VDPV circulation in Madagascar. Export of VDPV was noted from Nigeria into neighbouring Niger. Previous VDPV associated outbreaks have been recorded in India, Afghanistan and Ethiopia. All three have poor sanitation coverage. 35. This suggests that in addition to vaccination, attention should be paid to improving water, sanitation and hygiene if eradication of polio is to be achieved. A failure to do this would be likely to make complete eradication difficult. Promoting integration of WASH into GPEI may emerge as a candidate for channel 3 funding. 36. Climate risks are primarily those associated with emissions. These will come from various sources, including: international transport of vaccines to countries with no domestic source of the vaccine to support campaigns; in-country transport of immunisation teams; cold storage systems. These are not quantified and apart from trying to source quality vaccines as close as possible to countries there is limited action can be taken. As a hopefully medium-term intervention and the benefits anticipated, however, these emissions are considered an acceptable trade-off. There are no obvious climate benefits, although as with all health interventions the improvement in health and reduction in disease is likely to make poor people and communities more resilient to future climate changes. C. What are the costs and benefits of each feasible option? Counterfactual Option 1. Stop funding GPEI 37. With increasingly competing demands on aid budgets, eradication delays are causing some donors to reconsider polio support. The questions to consider under the option to cease funding are 1) Does eradication remain scientifically sound and technically feasible? 2) Is supporting polio eradication cost effective relative to other options? 3) How would UK cessation of support be perceived politically? 20 Scientifically sound and technically feasible? 38. Wild poliovirus type 2 is eradicated and the prospect of global eradication assumes the technical feasibility of eradicating WPV types 1 and 3. The challenge to contemporaneously interrupt WPV transmission across northern India led some to question the technical feasibility of eradication, but the biological principles remain sound.33 Humans are essential for maintaining transmission; to survive, the virus must be passed from an infectious person to a susceptible person in a continuing chain of transmission. When the infectious person comes in contact with an immune individual, that chain is broken. There is no animal reservoir of virus to reseed the population once polio transmission is interrupted. Additionally, unlike with some other diseases, there are reliable diagnostic tools that can determine who has polio so that intensive interventions can be specifically targeted to problem areas. The poliovirus currently persists in a few very limited geographic areas. If the eradication strategy can be successfully implemented in these places, polio can be eradicated.34 Cost effectiveness 39. Although several studies provided important economic support for polio eradication efforts, they had assumed that all polio vaccination would stop by 200535 or 2010,36 and so estimated lower costs consistent with achieving eradication earlier and with less intense efforts than GPEI is now undertaking. In 2011, Tebbens et al 37 updated their cost benefit analysis of the GPEI, to help inform and guide eradication and post-eradication policy. This study concluded that polio eradication remains economically justified given that the alternative (i.e. control) would lead to a very substantial increase in disease burden, unless expenditures remain extremely high in perpetuity.38 Depending on routine immunisation alone would achieve a steady state level of 160,000 to 200,000 cases per year, requiring US$ 500m each year over a 20-year period to simply maintain polio cases at this counterfactual level, as shown in Figure 5 below.39 33 Dowdle WR, Birmingham ME. The biologic principles of poliovirus eradication. Journal of Infectious Diseases 1997;175(Suppl. 1):S286–92. 34 Bill and Melinda Gates Foundation, Polio Eradication, A Must Win Battle in the Global War on Disease. February 2011 http://www.gatesfoundation.org/polio/Documents/polio-white-paper.pdf 35 Bart K, Foulds J, Patriarca P. Global eradication of poliomyelitis: benefit-cost analysis. Bulletin of the World Health Organization 1996;74:35–45. 36 Kahn MM, Ehreth J. Costs and benefits of polio eradication: a long-run global perspective. Vaccine 2003;21:702–5. 37 Tebbens, R., Pallansch, M., Cochi, S., Wassilak, S., Linkins, J., Sutter, R., Aylward, B., Thompson, K. Economic analysis of the global polio eradication initiative. Vaccine 29 (2011) 334-343. 38 Thompson KM, Duintjer Tebbens RJ. Eradication versus control for poliomyelitis: an economic analysis. Lancet 2007;369(9570 (April 21)):1363–71. 39 Tebbens, R., Pallansch, M., Cochi, S., Wassilak, S., Linkins, J., Sutter, R., Aylward, B., Thompson, K. Economic analysis of the global polio eradication initiative. Vaccine 29 (2011) 334-343. 21 Figure 5: Counterfactual disease burden with eradication vs. control Slide source: Tebbens et al 2011 40. The reported incremental cost-effectiveness ratios in both $ per paralytic poliomyelitis case prevented and $ per DALY saved. The base case focuses on the economics from the primary objective of eradication of WPV and excludes positive externalities from the programme’s support of measles campaigns, Vitamin A supplement delivery, contribution to bednet delivery, or use of its laboratory network in surveillance for other infectious disease, especially measles and other vaccine-preventable diseases. Sensitivity analysis was performed on the discount rate, ratio of internal to external contributions, assumptions about incidence in 198840, delay in achieving eradication, IPV prices, and assumed coverage level for the routine vaccination comparator. Under relatively conservative assumptions and focusing only on the 104 countries directly impacted by GPEI, Tebbens concluded that the incremental cost-effectiveness ratios for GPEI remain positive, with values typically considered “highly cost effective”.41 If each DALY averted is valued at the “typical” value of 1 per capita GNI42,43,44 then the incremental net benefit for global polio eradication compared 40 Incidence figures at the start of GPEI were less accurate than today and assumptions about baseline figures affect the counterfactual, and therefore influence the DALYs averted 41 Walker DG, Hutubessy R, Beutels P. WHO guide for standardisation of economic evaluations of immunisations programmes. Vaccine. 2010 Mar 8; 28(11):2356-9. Epub 2009 Jun 28. 42 In low-income countries, life expectancy is shorter and more life-timelifetime is spent in poor health. To measure the lost value of a healthy life year free of illness and disability, public health refers to disability-adjusted life years or DALYs. DALYsDALY's. DALY's combine the years of life lost due to premature death (mortality) and loss of full health due to illness and disability (morbidity). WHO's Commission on MacroeconomicsMarcroeconomics and Health has classified interventions that gain a year of healthy life (ie, a DALY averted) at a cost that is less than GDP per capita as very cost-effective. Gross National Income comprises the total value of goods and services produced within a country (i.e. its Gross Domestic Product), together with its income received from other countries (notably interest and dividends), less similar payments made to other countries. 43 World Health Organization Commission on Macroeconomics and Health. Macroeconomics and health: investing in health for economic development. Report of the Commission on Macroeconomics and Health. Geneva: World Health Organization; 2001. 44 Hutubessy R, Chisholm D, Edejer TT-T. WHO-CHOICE. Generalized cost effectiveness 22 to just routine immunisation is estimated at between US$40 and $50 billion from 1988 through 2035 when compared to routine vaccination. This result is robust to changes in assumptions tested under the sensitivity analysis (mentioned previously). In particular, it was concluded that a 3 year delay to 2015 for poliovirus interruption would not have a significant impact on the returns; this is important as 2015 now looks to be a more likely timeframe than 2012, as assumed in the base case. 41. Looking at the global public good benefits arising from eradication even more broadly, over a longer time period and a wider geography, leads to even greater returns. If the benefits of other health outreach efforts supported by GPEI are included, the returns are again multiplied. For example, from 1988 to 2010, it is estimated that GPEI workers administered up to 1.3 billion doses of Vitamin A during polio campaigns, averting at least 1.1 million deaths and creating an economic benefit of over $17 billion.45 Polio programme staff have also supported surveillance of and response to measles, tetanus, meningitis, yellow fever and cholera. Furthermore, GPEI has assisted with public health and humanitarian emergencies such as SARS, the Asian tsunami of 2004 and the Pakistan floods in 2010-11. Thus the option to cease funding eradication and revert to polio control can be immediately excluded on cost effectiveness grounds. 42. A 2013 BMGF-commissioned briefing provided further data on cost benefit.46 Consistent with previous studies cited herein, the briefing concluded that relying on current levels of routine immunisation would lead to a rapid resurgence of polio cases and result in hundreds of thousands of paralyzed children annually within a number of years. Pursuing a strategy of control may be less expensive than eradication in the next few years, but the cumulative costs of this approach over time (operational costs, but also productivity losses and treatment costs) would quickly overtake the costs of eradication, as shown in Figure 6 below. analysis for national-level priority-setting in the health sector. 45 Benefits from Vitamin A are not included in the past benefits of $27 billion referred to previously. Data source: Tebbens et al as summarised in “Economic Case for Eradicating Polio”, Briefing authored by GPEI and McKinsey and funded by the Bill and Melinda Gates Foundation April 2013 “Economic Case for Eradicating Polio”, Briefing authored by GPEI and McKinsey and funded by the Bill and Melinda Gates Foundation April 2013 46 23 Figure 6: Control has lower costs in the first few years, but the cumulative costs quickly overtake those of eradication 47 43. The briefing concluded that the investment of $9 billion since GPEI’s initiation in 1988 has already generated net benefits of $27 billion, out of the total estimated $50 billion from 1988 to 2035. Figure 7: GPEI has already led to benefits of $27 billion, and promises to generate another $15-20 billion48 44. Furthermore, even with an additional $5.5 billion invested, and continued investment by countries, the GPEI Plan can be expected to yield between $15 and Figure extracted from “Economic Case for Eradicating Polio”, Briefing authored by GPEI and McKinsey and funded by the Bill and Melinda Gates Foundation April 2013 48 Figure extracted from “Economic Case for Eradicating Polio”, Briefing authored by GPEI and McKinsey and funded by the Bill and Melinda Gates Foundation April 2013. Figure 1 in the Technical Appendix. 47 24 20 billion in additional net benefits over the next 20 years. These benefits apply to the 38 countries that are the core beneficiaries of GPEI funding49 and do not take into account the additional benefits possible over a longer time period globally. Politically feasible? 45. The option of UK cessation of support to polio eradication can also be excluded on political grounds. The Prime Minister has committed the UK’s continuing support publicly on several occasions, but also recognises the value of the challenge element to attract additional funding and particularly greater involvement by the remaining endemic countries. The UK has been a consistent and high profile advocate of polio eradication, influential on other funders but also in relation to the remaining endemic countries, especially Nigeria. The UK is ranked #2 among bilateral/ government donors behind the US. DFID’s funding has been pooled, untied and unearmarked in contrast to some others who tie contributions to specific uses or countries, the flexibility of DFID’s funding has been particularly important of late in the context of uneven and unpredictable financial flows which has threatened rational planning as well as campaign sustainability and breadth. A withdrawal of UK support would also go against the spirit of the World Health Assembly May 2012 declaration that the completion of poliovirus eradication is a programmatic emergency for global public health.”50 At the UNGA September 2012 meeting, under leadership of the UN Secretary General, world leaders gathered alongside traditional and new donors to show global solidarity and collectively make new pledges to not stop until polio is ended. UK Minister of State Alan Duncan reiterated the UK’s support and challenged others to do more. Most recently, the UK made a specific pledge of up to £300 million at the April 2013 Vaccine Summit. Option 2. A total package of £300 million provided to GPEI from 2013/14 to 2018/19 46. The rationale for providing increased funds relates to i) whether there is a funding gap between finance need and supply and ii) whether the funds can be justified in terms of cost-effectiveness. Establishing the funding need 47. A reasonable projection of the costs for the eradication and endgame period (2013-2018) is approximately US$750 million per year, or US$5.5 billion over 2013-2018. These costs represent the consensus position of the core GPEI partners, developed in consultation with the relevant global, regional and country stakeholders. The US $5.5 billion excludes Government of India funding of its own programme, at approximately US$1.1 billion over the same period. The major cost categories are shown in Figure 8. 49 Estimated benefits are to the 38 countries receiving technical assistance and supplemental funding from GPEI (majority of GPEI funding) Does not include the potential benefits to other countries covered by GPEI who receive only smaller amounts of funding. 50 Resolution WHA65.5 “Poliomyelitis: Intensification of the global eradication initiative” 25 Figure 8: Summary of external resource requirements by major category of activity, 2013-201851 Core Functions and Infrastructure 34% 2013-2018 (Indirect) Programme support costs (WHO and UNICEF) 6% Immunization Activities 44% Surveillance and Response Capacity 15% Poliovirus Containment 1% These major expenditure categories can be further divided as follows: Immunization Activities Planned OPV Campaigns (OPV) Planned OPV Campaigns (WHO Ops cost) Planned OPV Campaigns (UNICEF Ops cost) Planned OPV Campaigns (social mobilisation) Complementary OPV Campaigns IPV in Routine Immunization Surveillance and Response Capacity Surveillance and Running Costs (incl. Security) Laboratory Environmental Surveillance Emergency response (OPV) Emergency Response (operational costs) Emergency Response (social mobilisation) Stockpiles for emergecy response Poliovirus Containment Certification and containment Surveillance and lab enhancement for certification 718.30 901.81 168.98 140.79 175.62 301.30 2406.80 380.81 67.97 25.00 105.00 210.00 33.00 24.60 846.38 30.00 18.70 48.70 Core Functions and Infrastructure Ongoing quality improvement, surge capacity, endgame risk management, 400.11 OPV cessation, additional innovations Technical assistance (WHO) 825.95 Technical assistance (UNICEF) 223.87 Community Engagement and Social Mobilisation 369.87 R&D and Technology Transfer 60.00 1879.80 51 http://www.polioeradication.org/Financing.aspx - 26 These costs are in US$. There is an additional $343m which represents the estimated programme support costs of WHO and Unicef based on each organisation’s official policy. 48. The proportion across key budget categories will be adjusted as progress against key milestones is evaluated. Adjusting the estimated year of interruption will increase/decrease costs accordingly. 49. During the eradication and endgame period, OPV campaign activity will remain high through 2015, and then gradually decline. Technical assistance and surveillance costs will remain relatively stable throughout the period. Some costs, such as those for innovation and campaign quality improvement, will decrease following interruption of transmission. Other costs, such as the use of IPV and OPV in routine immunisation, will continue well after interruption. Cost drivers 50. The US$ 5.5 billion budget is based on the following key assumptions52: Interruption of residual wild poliovirus transmission by end 2014; Complementary OPV campaigns to boost type 2 immunity before tOPV to bOPV switch and allow for additional coverage as needed between 2014 and 2015, then declining post-interruption; IPV used in routine immunisation at 1 dose/child starting at 50% uptake in 2014; then 100% from 2015-2018;53 Surge capacity in endemic and high-risk countries to interrupt transmission; Maintaining technical assistance staff at 2013 levels through 2018;54 Maintaining Global Lab costs at 2013 levels; Maintaining research and product development at US $10m/year; Maintaining environmental surveillance55 at US $5m/year; On-going quality improvement, surge capacity, endgame risk management, OPV 52 The assumptions and the modeling were made separately by the Bill & Melinda Gates Foundation, and then jointly by WHO and UNICEF, summarized in the Polio Eradication and Endgame Strategic Plan, May 2013Dec 7 2012 53 One dose of IPV per child to be included in the routine immunisation schedule, ideally at 14 weeks after birth. 54 If transmission is interrupted by end 2014, this will only be known in 2015. Countries will then have to maintain intense level of activities for at least 3 years to ensure that they maintain zero cases, before the countries and then the regions can be considered as polio-free. So, for at least the last few endemic countries, the staff level will have to remain the same through 2018, though in the final periods the emphasis will be on enhanced surveillance, in addition to ensuring high quality SIAs. 55 As countries with endemic and re-established transmission approach the interruption of virus circulation, it becomes increasingly urgent for the program to be able to use surveillance systems which reliably detect whether or not polioviruses are still circulating. In addition to high-quality AFP surveillance, environmental surveillance (i.e. regular sewage sampling for polioviruses) is now being used in several countries (India, Pakistan, Egypt and Nigeria) to accomplish that objective. (i) Pakistan: Environmental surveillance for polio viruses continues in Pakistan. In November of 2012, there were 20 collection sites in four provinces. Wild polioviruses were detected on multiple occasions during 2012. (ii) India: Environmental surveillance continues in Mumbai (3 sites), Delhi (5 sites), Patna (3 sites) and Kolkata (2 sites) in India. No poliovirus was found during 2012 in sewage samples from India. (iii) Nigeria: In November 2012, there were 7 environmental sampling sites (4 in Sokoto and 3 in Kano) providing regular sewage samples. Both wild as well as vaccine derived polioviruses were detected on multiple occasions during 2012. Future Plan for 2013-14: In conjunction with regular surveillance reviews and the application of rapid surveillance reviews, environmental surveillance sites will continue to be used to provide another layer of surveillance to either detect WPV or VDPV cases and to ratify progress. At present, the interagency working group on Expansion of Environmental Surveillance is drafting new guidelines and plan for expansion of environmental surveillance. The plan (in its draft form) calls for expansion to 10-20 new sites globally by mid-2014. 27 cessation, additional innovations and program adjustments costs of US$ 416.6 m between 2013 and 2018; Outbreak response of US$ 66 m in 2013 and then held constant at US$ 75 m through 2018; Social Mobilisation is held constant at 2013 levels through 2018 (US $66 m annually); Stockpile Projections56 for 2014 (US $24.6 m) based upon existing contract(s). 51. The key budget drivers are: the number of OPV campaigns, vaccine costs, technical assistance to countries, surveillance and laboratory costs, outbreak response capacity & stockpiles, IPV use in routine immunisation. 52. Though the costs have not been modelled beyond 2018, some modest funding will be needed past the point of certification – including for limited OPV campaigns (for responding to any wild or vaccine-derived poliovirus regardless of serotype due to outbreaks or release from laboratory, or production facility) and technical assistance continuing into 2020. Additionally, certain costs such as certification and containment, AFP surveillance, environmental surveillance, and lab costs, will need to continue for up to 7 years post certification. Establishing the funding supply 53. As Box 1 showed, a funding shortfall to meet the US $5.5 billion budget remains, even including the DFID pledge. Shortfalls in donor funding in previous years have obliged GPEI to make choices and cancel supplementary immunisation activities (SIAs) in relatively lower risk countries. Cutting back on SIAs in this fashion has the potential to increase the risk of outbreaks. Outbreaks can temporarily raise costs above counterfactual levels (when polio eradication becomes more expensive than the benefits), with resultant pressure on eradication timelines, further prolonging costs. GPEI earmarks a part of the annual budget (see para 50) to finance start-up emergency response activities and organises additional appeals or campaigns if the situation justifies this. The main risk of a funding shortfall is the potential to increase costs, prolong the higher costs period prior to eradication, and avert fewer DALYs.57 It is difficult to forecast year on year funding gaps given that U.S. commitments can only be confirmed annually, and uncertainty over Rotary campaigns. DFID’s increase from its previous commitment of at least £20m per annum goes some way towards reducing GPEI 56 Expectations are that OPV demand will decrease in line with eradication progress. From the vaccine producers’ standpoint, a three year period is needed to shut down production and clear supplies, thus the prospect of polio elimination poses a risk to producers of being left with residual vaccine bulks. The programme risk thus becomes that of producers consequently closing down production prematurely, risking sustainability of supply. Supplier productive capacity in OPV needs to be maintained as long as there is a risk of re-importation of wild polio virus, particularly from the countries where polio remains endemic. Thus, GPEI and UNICEF manage a polio vaccine stockpile in order to avert the risk of OPV supplier exit, to preserve the benefits achieved through eradication, to manage residual circulating vaccine-derived polioviruses (cVDPVs) at the time of tOPV cessation, and to prepare for the possibility that the causal agent (wild poliovirus) could be re-introduced. (Source: IFFIm Evaluation, HLSP June 2011) 57 Although delays in eradication substantially increase the total costs of the GPEI, Tebbens et al showed a relatively small decrease in expected net benefits associated with a delay of eradication of 3 years, with high financial costs and cases through 2015. This is due to fact that continued prevention of paralytic cases and consequent benefits during the delay period would limit the impact of DALYs on the overall net benefits of the programme. The result (of a minimal cost effectiveness impact of a three year delay) is also a function of the timescale of the Tebbens et al analysis, which looked at programme costs and effectiveness from GPEI’s start in 1988 until 2035. Over a reduced timescale of 2013-2018, the increased spending resulting from delays to eradication would have a more substantial impact on the overall net benefits. 28 funding shortfalls, but does not rule them out. 54. As well as maintaining the support of the core group of funders, GPEI needs to recruit new sources of funding from donors, including among the G20. It also needs to see endemic countries (following India’s model of paying for its domestic eradication effort in the last few years) contributing a greater share of their own domestic resources for polio, routine immunisation and health systems strengthening. Nigeria has pledged $90m to the national polio programme since January 2012, an increase on previous years but far short of need. Are extra funds justified on cost effectiveness grounds? 55. Tebbens et al found a cost per DALY saved of US $210 in low income countries, assuming eradication is followed by IPV. Thus, under this assumption, DFID’s £300m (US $450 m) contribution towards eradication translates to averting 2.14 m DALYs over the period 2013 – 2018. 56. Another way to look at the return to DFID’s investment is to take the net benefits of approximately US $50 billion and calculate what proportion of the overall programme DFID has funded since inception. The total UK contribution by end 2012 was £600m; adding the £300m to 2018 brings the total UK contribution to £900 m. Combining the US $9 billion spent on eradication since 1988 with the US $5.5 billion budget to 2018 equates to roughly £9 billion in costs over the lifetime of the programme. If the UK contributes £900 million towards the total of £9 billion, then the UK will have funded approximately 10% of the US $50 billion in net benefits. This excludes any leverage effects on funding from other donors, DFID influence on performance of the programme, and the externality health benefits of GPEI, detailed previously (e.g. global public good and benefits from Vitamin A coverage). Figure 9: Alternative calculations on investment Option 3. A total package of £300m 2013/14 - 2018/19 routed through three channels 57. Channelling all UK support via GPEI (Option 2), would send a signal that a fullyfunded business as usual approach will be sufficient. The challenges underlined by the strategic case demonstrate that the Option 2 approach will fall short,running counter to the UK’s role as a leading and critical partner. Recognising the 29 Strategic Plan’s assumptions and considering the UK’s concerns requires a strategic response that reaches beyond just financial support to GPEI: on the one hand, this may be continuing to keep up momentum and commitment from other donors and on the other , directly addressing some of the challenges to eradication in the remaining endemic countries. Despite evidence of GPEI’s greater ambition as witnessed by the Strategic Plan, and its improved understanding of the residual key issues, GPEI’s implementation capacity remains untested in view of the Plan’s greater complexity. Donors will monitor GPEI capacity, flexibility and adaptability in responding. To achieve results, the allocation of funding under Option 3 will be further diversified by adding a third channel: a) b) c) A predictable annual contribution to GPEI; An amount conditional on GPEI leveraging new commitments from others either globally or directly against endemic country plans and aimed at improving GPEI performance channelled to the central programme run by GPEI; An innovative funding window to respond to local demands for a broader package of health programmes in endemic countries (mainly, Pakistan and Nigeria) including routine immunisation support or broader health services, to create wider benefits for communities in polio endemic areas, and to support risk mitigation investments. 58. The justification for Option 3 – First Channel: a predictable annual contribution to GPEI has already been made under Option 2. Decisions about the precise allocations to be channelled to GPEI, either in a predictable way or through a challenge fund based on others’ performance, will be guided by programmatic needs as well as programmatic options made possible with DFID’s contribution i.e. how much is needed to leverage additional funding from others or improved performance from GPEI This is the subject of the following sections. Option 3 – Second Channel of funding: Leveraging in further donor funding and improving GPEI performance 59. Over the period 1 January 2011 to 31 December 2012, the UK established a challenge fund of £20m per annum, in order to help GPEI expand the donor base and strengthen sustainable financing options. For every £5 pledge by others, the UK increased its support by £1 up to a maximum of the additional £40 million announced, and subject to increased strengthening of routine immunisation. GPEI deployed this offer in its negotiations with other funders, and under this agreement. As a result, the additional £40m that the UK provided generated an additional £200m of new money. 60. This was very effective in enabling GPEI to leverage in additional funds. It achieved its objective each year, and was straightforward to monitor and operate. Extending the mechanism by the same ratio can be expected to generate £200m additional financing in response by end-2015. Table 3: Pros and cons of the challenge fund mechanism. Pros Cons 30 Provides GPEI with a negotiating tool to incentivise other funders deliberating over whether to commit funds Potential for UK government to leverage in funding from other donors, incl. new funders or those with political influence UK funding can be well justified to tax payers because every £1 of UK spend is worth an additional £5 Other governments and organisations can make the parallel argument to their constituents (that their funding is matched by the UK government, so has higher value) Leveraging helps donor governments demonstrate this remains a group effort May reduce predictability (from DFID’s management perspective) of DFID release of funds Reduces predictability of funds for GPEI, though as long as the challenge funds are additional to core funds, this risk is minimised (The option of) setting different ratios for different groups would require some upfront administration time and negotiation to consider what ratios are appropriate for which different groups The differential options ratio has potential to create agency problems – GPEI has incentive to make “old” donors look new or influential Difficulty of attributing the “levered” funds to DFID’s challenge as opposed to other factors 61. A Mid Term Review (MTR) in FY 2015/16 will judge the Plan’s effectiveness and DFID’s contribution to inform allocation decisions in the light of MTR findings and recommendations. The challenge mechanism could then be adapted for the remaining grant, offering a higher ratio for attracting funding from completely new sources and/or funding from groups whose support is viewed as politically influential to elimination. 62. In addition to challenging others to increase funding, the mechanism should also incentivise GPEI to improve its performance, solve difficult operational problems, and reduce negative effects on other health services. Alongside the additional resources that Option 3.2 (Second Channel) funds will aim to leverage, GPEI performance will be expected to meet two important quality markers to be agreed but which could include: ensuring that routine immunisation services continue to improve alongside polio; risk mitigation in Nigeria and Pakistan around the incentives for paid polio vaccinators to work for success; or broader research to improve health service delivery alongside polio vaccinations. 63. The aim of using performance markers in addition to leveraging other donors’ funding is to ensure GPEI sustains its focus on the underlying challenges to interrupting transmission in the three endemic countries which require specific, bespoke plans. The UK is funding routine immunisation services in a number of ways including through bilateral programmes, GAVI, and the Measles and Rubella Initiative.GPEI-led efforts to eradicate polio should complement broader immunisation services and at best, strengthen these services so that polio is better embedded within a full range of immunisations that every child expects to get. 64. The performance markers arrangement will apply from FY 2014/15. The submission to Director/ Policy to approve the release of funds from 2014 will cover the extent that new funds have been leveraged and an assessment of GPEI performance against the agreed indicators. Option 3- Third Channel: improving primary health services and responding to broader needs 65. It is clear from the strategic case that financing is not the sole risk and polio is no longer just a health (medical) issue. DFID’s package of support needs a more comprehensive approach which is supportive to eradication and additional to 31 GPEI. The objectives will be complementary in order to (i) secure funding, political will and enhanced partner co-ordination, (ii) enable a more secure supply chain and improved delivery and (iii) ensure that polio programming is leveraged to the benefit of public health, community development and conflict resolution in the remaining endemic areas. This will help maintain efforts to hasten eradication without harming other important human development outcomes. 66. To achieve the objectives in the Theory of Change under “Polio programming leveraged to advantage of overall public health, community development and conflict resolution” (Box 2) DFID will establish a funding channel that supports risk mitigation investments in polio endemic areas. This will require more detailed design considering each country context. The goal of this funding stream is to add value to the core investment. These investments may support improved or broadened primary preventative services, or other responses judged to be what is needed to ensure polio eradication success. 67. As such, the funding mechanism must be flexible to enable responsive work to be done where the need is identified. The right funding channel and/or service provider will need careful consideration to fit the purpose. Each drawdown against this budget line should meet the following conditions: 68. Be developed by the DFID country office in cooperation with partners in country, including federal, state or local authorities as appropriate, the BMGF, WHO and UNICEF among others; Be approved at the appropriate level of authority in a joint submission from the DFID head of Office of Nigeria, Pakistan or other country head if appropriate eg the programme is in an outbreak country, and the head of Human Development Department; Followed by a succinct business case that includes a logframe and monitoring plan; Expect to match funds made available by State authorities or other in-country partners in order to leverage greater policy influence and avoid DFID as sole funder where the programme is newly initiated (some programmes may be enhancements of existing DFID or other funded programmes, so this requirement may not apply). 69. Although there is a strong case for additional funds to be channelled alongside the global polio effort along the lines set out here, there are arguments for and against this option (see Table 4 below) which will form the basis for a checklist of possible applications. Table 4: Pros and cons for a bilateral funding channel Pros Cons Polio embedded in a wider Risk that the incentive/reward is too small, or not programme of services, so democratically allocated towards community needs. communities may value it more Requires good community knowledge and mobilisation. Resistance to vaccination expected to Risk that the key programme barriers may not be decline susceptible to increased resources or financial incentives Programmes and services which are Risk that taking on too much of the financial burden valued become less easy targets for reduces local ownership, accountability and violent groups discipline 32 Health gains realised from other Risk that taking on too much of the financial burden health services and strengthened makes the programme appear to be externally routine immunisation driven (heightens suspicion) Non-health benefits of conflict Reduces predictability of funds for GPEI, though as reduction and community long as the performance based funds for countries empowerment are additional to historic GPEI core funds, this risk is minimised DFID already has existing country Requires time of country offices to manage and programmes through which additional may require addition human resources to be placed funds could be channelled. at country level. A table measuring the three options against the evaluation criteria is below. Option three is the only one that meets all the criteria. Criteria/Option Cost-effective Value for money Comprehensively addresses obstacles to eradication Option 1 No No No Option 2 Yes Yes No 33 Option 3 Yes Yes Yes Theory of Change: Box 2: Theory of Change for DFID support to polio eradication Colour coding key: 34 Impacts/MDGs Ultimate outcome/Programme goal statement Broader results/intermediate outcomes Direct programme interventions Inputs/Funding streams Notes to the Theory of Change The three main categories of work will need effective management to achieve eradication. GPEI, UK and other stakeholders can assume different and complementary roles in tackling the challenges: - The supply chain must be secured and delivery effectiveness enhanced. This area has been the foundation of the programme since its outset – for example, how missed children can be found and vaccinated, how to secure the cold chain, how to improve micro-plans. The areas for improvement are well elaborated in each IMB report, GPEI works diligently to resolve the issues, and the GPEI M&E plan is dominated by measures to ensure that they are making improvements in this area. The other two categories have received relatively less attention. They are areas requiring the UK (and others) to exert continued leadership and innovative thinking: - Political willmust be demonstrated and funding secured. GPEI has become better at holding high level discussions with partners regarding current risks to success, and the UK has been a key partner in this process. GPEI has consequently started to harness Islamic leadership and is beginning to integrate conflict assessment and political analysis into its approach. The UK continues to advocate with partners for increased investment in RI systems strengthening and will hold GPEI accountable for this. The UK is helping GPEI to close its funding gap by providing not only core, predictable funding but the incentive of matching grant funds to help close off the GPEI budget gap. - Polio programming must be leveraged to the advantage of public health, community development and conflict resolution. GPEI has taken on board that routine immunisation strengthening must go hand in hand with eradication. GPEI is also working on how its investments can be leveraged to the benefit of other health programmes through the polio legacy strategy development process. Identifying and meeting community needs is a key step in addressing elimination. DFID is prepared to invest through the third channel to enable the provision of a broader health care response by local authorities. The assumptions behind the boxes in the Theory of Change are detailed in the following paragraphs, grouped into the three pillars of work which are not discrete, but linked: 1. Assumption: Securing the supply chain and increasing delivery effectiveness is fundamental to improved value for money and achieving eradication. 70. Although this category represents GPEI core business as usual” – the area of 35 traditional focus of GPEI – it remains is an area which is core and fundamental to success and needs support to continue to receive attention. The most recent IMB report58 acknowledges the programme’s success in using new tools and strategies to find missed children, such as the vaccine-related and operational innovations which were key to eradication in India. However, the transition to IPV presents new challenges including the need to work more closely with GAVI and determine when it is best to deploy IPV. GPEI continues to refine their approach to this and other challenges; a recently commissioned and independent VfM review identified some “quick win” areas for greater efficiencies, which are detailed in the VfM section below. Two other key pillars to achieving success are only now receiving more attention by partners. The UK can have considerable influence: 2. Assumption: Strengthened policy, dialogue and co-ordination are required in order to secure adequate funding and political will. 71. This pillar of work influences the supply chain and programme delivery effectiveness, for example heightened political commitment drove through a raft of programmatic improvements in Pakistan, incorporating political analysis in microplanning will be required to safeguard safety of polio workers, and a predictable funding base will enable GPEI to plan investments and respond to outbreaks more rationally. 72. The new UK funding to polio eradication through the GPEI should be contingent on more openness, better quality (more objective) and more regular review in endemic countries and an active approach to ensuring routine immunisation services are not undermined by oral polio campaigns. In all endemic countries the UK will work closely with government authorities, WHO, and UNICEF in order to advocate for more investment in routine immunisation systems strengthening. As described under Option 3.1, the UK will also provide additional funding to GPEI on a matching funds basis, so DFID funds will be levered up by additional donors matching contributions, bringing it to the total required of $5.5 bn. 73. The advocacy position that “we are almost done with polio and just need to keep going and give one final heave” makes it difficult for partners to talk frankly about problems and challenges needing a new approach and communication strategy. The orthodoxy has led to oppositional positions rather than consensus and a problem-solving approach. Ironically, this puts the success of the programme at risk. The UK will support high level and proactive discussions with relevant partners (including WHO, UNICEF, the Pakistan and/or Nigerian governments, and the BMGF) engaging the full range of UK resources across DFID and DH to be clear about the current risks to success in Nigeria and a strong message that coercion and physical violence are creating resistance; confrontational tactics will not lead to successful eradication, and; an unwillingness of GPEI partners to discuss tactics will make the situation worse not better. 74. We also know that in both northern Nigeria and Pakistan, polio vaccination is viewed with some suspicion. The result has been an increase in refusals and violence against health workers. If vaccination refusal becomes further entrenched, this will not only halt polio eradication, but polio will become an issue 58 Independent Monitoring Board of the Global Polio Eradication Initiative, May 2013 36 around which confrontation occurs rather than one supporting human development outcomes. The programme needs a better understanding of how the polio eradication campaign fits into political dynamics, why it becomes a target for violent groups and what could be done differently to resolve or undermine this. Conflict assessment, political analysis and research funded from the third channel will be integrated into polio eradication as norm. 75. Radical Islamic groups have for various reasons decided to target the polio eradication campaign. Counteraction of the Taliban with a fundamentally Islamic position, rooted in Islamic teaching, is being explored, along with the authority that comes from Muslim leadership and respected public health academics of Muslim heritage.59 3. Assumption: Meeting community needs will not only facilitate polio eradication but will also contribute towards meeting overall public health needs, furthering community development and reducing conflict. 76. Political commitment at the highest levels and effective programme management and delivery systems mean little if the endemic communities do not demand the polio vaccine. Many endemic communities feel ambivalent about polio vaccination because they hardly see any cases, and it is the only health service they receive. In the view of many, their main public health issues (diarrhoea, pneumonia, maternal health) are not being addressed and fixed clinic services practically shut down during monthly polio campaigns. There is a need for better information about what local communities do value and what they want from their local governments in addition to understanding views about polio better. Given the fact that polio eradication is not valued by communities, it has become an easy target for violent groups. UK officials are exploring options, including with the B M G F to support a broader range of actions in each of the endemic countries in order to shift the dynamic away from polio vaccination as a highly-visible, vertical service towards one where community demand for a range of services is more effectively met by a responsive local government authority. This will require a longer term effort and will start with a better analysis of what communities value, why they may feel ambivalent about polio vaccination and how the international community could better support national and local authorities to respond to legitimate community demand for health services. Meeting community demands for improved services and a better quality of life is a critical part of building state – citizen trust. Government and partners need to listen carefully to what people are really asking for especially where that reaches beyond health services (such as access to water, sanitation, nutrition and so on). Polio will be more welcomed and valued where it is provided alongside a range of services people value. 77. Extensive discussion with the Nigeria and Pakistan country offices has informed the design of the programme and helped determine how DFID might intervene. The programme will draw on relevant DFID material to shape the parameters and likely approach of these programmes. These include Country Governance Analysis, Conflict Audits, Post Crisis Needs Assessments, Corruption and Gender Assessments, Political Economy Analysis and lessons learned elsewhere around community engagement, changing social norms and building demand for “Poliomyelitis in Pakistan: time for the Muslim world to step in”. Ahmed, Q. et al, The Lancet, Vol. 381, May 4 2013. 59 37 services especially in the context of conflict situations. In the near term, the next phase of the northern Nigeria mother and child health programme (in development now by the DFID northern Nigeria team) should support community outreach, build demand for quality services and trust between service providers and communities. Such strategies need to inform GPEI’s operational programming as well. The most recent IMB report acknowledges the important role of communities, but underlines that communications and advocacy need to focus clearly to influence these communities. Although the UK agrees with this analysis, DFID support is focused less on influencing and persuading and more on meeting the legitimate needs of communities, and in this way, building more genuine demand for polio vaccination embedded within a range of services. The third channel funding provides the platform for pursuing this agenda. 78. The evidence from Nigeria and Pakistan is that RI suffers as a result of the contrast with the intense energy put into polio campaigns. Investing in strong, sustainable routine immunisation systems is not only critical for saving lives from other preventable diseases but is central to the legacy plan for polio, posteradication. The additional funding stream allows relevant DFID (and other stakeholder) country programmes (Nigeria and Pakistan mainly) to draw down additional funds to boost routine immunisation and other public health services in polio endemic areas. Recent modelling reveals the benefits of improving RI in just one of the focus countries, Nigeria. Improving the low RI rates, which were approximately 47% in Nigeria in 2011 for DTP3, according to WHO, by increasing immunisation coverage by 10% annually between 2014 and 2018 could save ~30-35,000 lives and translate into an economic benefit of ~$4 billion by averting economic productivity losses. Although many institutions contribute to improved immunisation coverage, and GPEI and its workers already support other immunisation activities, the GPEI intends to increase this focus over the next several years.60 79. Through creating a flexible funding window, DFID offers countries – and where more appropriate, sub-national government - greater power and choice over what interventions will be appropriate, based on evidence. The objective is to underpin a broader package of health programmes at country level to create wider benefits for communities in polio endemic areas and shift the focus away from polio vaccination as a vertical and isolated service to one embedded within a broader health care response by the local authorities. DFID will channel funds through intermediaries with the best information on community needs and how to meet them. 80. Longer term, as part of the “polio legacy” programme, GPEI will be working on a strategy to transition its staff infrastructure and knowledge to the benefit of other health programmes. Once GPEI assets have been mapped, consultations will begin, and decisions taken on the benefits and risks of various legacy proposals. Spending Profile 81. The projected profile of GPEI funding need, as it relates to spending plans, is provided in Figure 10.61 “Economic Case for Eradicating Polio” A briefing authored by GPEI and McKinsey and funded by the Bill and Melinda Gates Foundation April 2013 60 61 Global Polio Eradication Initiative Financial Resource Requirements 2013-2018 November 2012 presentation by GPEI 38 Figure 10: GPEI Funding Needs 82. Ministers approved a UK pledge of up to £300m to support polio eradication over six years (2013-19) which will be channelled in three ways: A predictable, annual contribution to the Global Polio Eradication Initiative (GPEI); An additional annual contribution to GPEI through a challenge fund; A funding window to support GPEI objectives in endemic areas by tackling barriers to uptake –and responses to unmet community child health needs. How to disburse this commitment? 83. We should retain flexibility about the disbursement of funds across these channels over the six year programme timeframe. Over its lifetime, DFID will adapt the grant to respond to unforeseen events and needs, and incentivise and reward well-evidenced shifts in GPEI’s approach in endemic countries. The pattern of recent UK commitments 84. Over the last two years, the UK increased its spend from its set £20m annual allocation. In 2011/12 it reached £65m; in 2012/13 it was £40m. These contributions were linked to the Prime Minister’s challenge fund announced at Davos in 2011 (leveraging additional commitments at a rate of 1:5) and to challenging the Gates Foundation to help close the GPEI 2011 budget gap. It has been exceptional but not unusual for the UK to make payments to GPEI either as part of a challenge fund arrangement or to meet a one-off need. One aim of the increased UK pledge at Abu Dhabi was to reduce the likelihood of ad hoc funding requests while improving financial flow predictability for GPEI. The aim has been to cover about 9% of the polio eradication budget overall. The 2013 budget gap 85. We are working closely with GPEI as they firm up the timing and reliability of other Abu Dhabi vaccine summit pledges made in April 2013. We are planning a £100 39 million contribution for 2013. This would represent 14% of the year’s budget and compares to £65m in 2011/12 and £40m in 2012/13. The Abu Dhabi pledging estimate (Box1) assumes a $90m US contribution, and $80m from Rotary International in 2013. US appropriations are decided annually, hovering between $130m to $150m in recent years (though not all against the GPEI plan). Provided the US and RI maintain their historic levels of support and all other commitments are honoured, GPEI will be only $0.6 billion short of the 6–year $5.5 bn budget. However, the distribution of these commitments appears to be back-loaded, and some may not be realised. In May 2013 GPEI reported an outbreak in the Horn of Africa. To offset the additional costs of containment (currently set at $42.5m or £28m) the UK contributed £10m from regional funds. 86. Front-loading has several benefits for GPEI which has significantly strengthened its coordination and outreach efforts this year, partly in response to frank discussions while writing the Strategic Plan with donors including the UK and the Independent Monitoring Board. There is evidence ,from the Plan’s layout and contentof due recognition by GPEI of the risks, and of acceptance of the importance of polio linking with strengthening routine immunisation. Adequate funds in 2013 will give GPEI a chance to implement its new plan comprehensively, address the Horn of Africa outbreak, and prove that it can deliver stronger results for polio and routine immunisation. The challenge fund is one means to drive the necessary shifts from 2014. The third channel is innovative, and will need new research and partnership building, and time to build. But once established, and assuming it proves its worth, we will want to ensure we can give it sufficient funding to clear bottlenecks to eradication. Beyond 2013 87. The table below provides the indicative distribution of funding across the funding channels and over the six year strategy timeframe. It assumes a scaling back of funding to GPEI after year one as other pledges come into play, a build-up in the third channel to a peak in the middle years and a general tapering off of eradication costs in outer years in line with GPEI predictions. Levels of third channel funding reflect an expected focus on technical assistance, research and some financial support to boost services and demand creation – and to trigger transformation in GPEI investment. However we retain flexibility to switch investment across channels depending on results and needs year on year. Table 5: Indicative funding flows and distribution of £300m for polio eradication Year 2013/1 4 2014/1 5 2015/1 6 2016/1 7 2017/1 8 2018/1 9 Total Core funding Funding Window £100m Challen ge funding £0m £25m £25m £12m £100.25 m £62m £15m £15m £15m £45m £15m £10m £15m £40m £10m £10m £15m £35m £5m £8m £4.75m £17.75m £170m £68m £62m £300m 40 £0.25 Total D. What measures can be used to assess Value for Money for the intervention? 88. The GPEI recently evaluated costs throughout implementation and sought opportunities to ensure good stewardship of available resources. In recent years, reviewing the costs associated with SIAs in countries such as Chad and DR Congo led to substantial reductions in operational costs. GPEI recently commissioned an independent VfM review, which identified some “quick win” areas for greater efficiencies: 1) Improvement of training quality and reduce frequency; 2) Increase OPV buffer policy adherence through better OPV management;62 3) Improve process and incentives linked to target population estimates. More detailed findings are summarised below, along standard value for money dimensions of economy, efficiency, and effectiveness.63 89. For Third Channel interventions, we will assess value for money for each individual proposal on economy, efficiency and effectiveness grounds, drawing on the evidence including from other DFID-funded programmes in country. The grounds will provide the basis for monitoring, and to inform elements of evaluation. Economy 90. Key inputs for GPEI are: Staff and consultants Vaccines and associated commodities Programme operational costs which are affected by issues such as target population size and the number of Supplementary Immunisation Activities planned 91. As part of the VfM study, staff and consultant salaries were examined and the conclusion was that some further cost shifts could be made. WHO and UNICEF are now working together on a long-term planning concept paper that lays out the potential approach for the GPEI to map existing resources and develop a plan to transition these resources towards and beyond 2018. 92. Work by GPEI partners has helped reduce the cost of IPV: most notably, in January 2013 the Indian Serum Institute announced it would enter the injectable polio vaccine market with a vaccine costing as little as $0.70 in multi-dose vials (compares with about $2.50 per shot now). A reduction in the price of IPV is critical as GPEI works towards the international switch from OPV to IPV in 140+ countries. While a variety of factors influence OPV costs, the GPEI Financial Reporting Requirements document in 2012 stated that the weighted average OPV price reduced in 2011 and again in 2012. The cost of OPV was also recently examined under the GPEI VfM study in the context of the overall amounts of OPV ordered for 62 Prior to the tOPV-bOPV switch, as OPV will be the vaccine of choice to respond to all wild and VDPV outbreaks, during this period, global OPV supply will be managed to ensure a sufficient buffer stock (i.e. a minimum of 50 million bOPV doses) is maintained for this purpose. All polio priority countries are expected to maintain enough OPV buffer stock in the country that is sufficient to quickly conduct the first response activity to respond to any outbreaks 63 www.nao.org.uk/sectors/third_sector/successful_commissioning/successful_commissioning/general_principles/ value_for_money/assessing_value_for_money.aspx 41 different countries and campaigns. It was concluded that some work could be done to improve OPV management and distribution. In the past, some countries have tended to over-order OPV in order to ensure sufficient supplies: this led to excessive buffer stock and inefficiency. In 2012, countries have used improvements in planning tools and data to more accurately predict and order the necessary OPV supplies. This trend will continue, by working closely on the microplans that direct SIAs, examining order volume differences across countries and investing in tighter tracking of vaccine in-country. 93. Looking at overall programme costs, the VfM study concluded that some further work would improve use of household data rather than the less reliable population data to improve operational planning. This is the subject of further work now among GPEI partners to ensure the target population numbers are as accurate as possible. In addition, the VfM study has led to further discussions amongst GPEI partners to ensure the rate of SIAs more consistently matches risk-levels across countries and to consider where it might be possible to reduce the number of SIAs. Efficiency 94. GPEI has been criticised for insufficient organisation of the polio eradication campaign, particularly in Northern Nigeria, poor and inadequate communications about campaigns, weak leadership especially from multi-laterals and badly structured incentives for those doing the work of polio eradication on the ground. Both the Expert Review Committee (ERC) for Nigeria and the the Technical Advisory Group For Afghanistan and Pakistan (joint-chaired by Professor Salisbury from the DH) are reviewing their information sharing and communication strategies. With other donors, the UK will continue to engage WHO and UNICEF on performance improvement and identify actions to be undertaken in the short and medium term to improve UN coordination in the field, especially in Nigeria, around polio and routine immunisation. GPEI and GAVI are identifying potential synergies and opportunities for cost-sharing. GPEI is aware of the need for more efficient operations, and for example, is working to improve the training frequency and training quality to make more efficient use of staff and volunteers’ time. In Nigeria the programme may reduce the number of SIA training sessions for volunteers and shift savings to increase the number of small staff teams who can focus on different geographical areas to improve the impact of SIAs. Improving training is particularly relevant in areas with high SIA frequency, where trainings are of low quality, or too numerous at the cost of effectiveness or thoroughness. Some countries are already reducing training frequency while concentrating on making it more effective. The finding is particularly relevant to vaccinator training, where the turnover should ideally be low. The endemic countries are now reviewing their training programmes to identify potential cost shifts. 95. Addressing training quality is essential where changing circumstances in a country or the content of the training may influence decisions made about frequency of trainings. In Pakistan, the introduction of the Direct Disbursement Mechanism will lead to a turnover in vaccinators, requiring more training in the short-term. In social mobilisation, the need to improve inter-personal communication similarly require more frequent training in the short-term. The value in this case rests in more effective training and improved performance of front-line workers, with the funds available. Effectiveness 96. Since 1988 GPEI has led the global effort that has resulted in a reduction in polio 42 cases from 350,000 a year to 223 in 2012. In part this historic success has been due to the introduction of new tools and strategies. For example the bivalent oral polio vaccine (bOPV) rolled out since the end of 2009 has proved highly effective at simultaneously reducing polio types 1 and 3. Use of bOPV has played a significant role in reducing polio cases worldwide. In India, the use of bOPV and intensified campaign activities helped stop wild poliovirus transmission., with the last case reported in January 2011. The use of bOPV has also helped reduce the number of wild type 3 poliovirus cases – from 1,122 in 2009 to 21 cases in 2012. In Asia, the last type 3 case was detected in Pakistan in April 2012. The further roll out of bOPV is a key element of the 2013-18 Polio Eradication and Endgame Strategic Plan. Technical (vaccine-related) innovations are only part of the picture; GPEI has also used social and operational innovations which have improved performance in reaching missed groups , for example: Employing innovative and tailored approaches to reaching inaccessible population segments. In the last 3 months of 2012 more than 8000 previously unrecorded settlements were identified in Northern Nigeria ensuring thousands more children were successfully vaccinated. Employing new technologies to improve the programme’s effectiveness e.g. the use of GIS mapping and GPS tracking of vaccination teams has helped improve micro-plans and increase numbers of children reached by ensuring teams fulfil their daily vaccine schedules. The new settlements identified, and the improved micro-plans prepared by the polio teams, have helped health authorities provide other vaccination services and health interventions to previously missed communities and children. 97. Effectiveness in delivering health outcomes has also been enhanced by the concurrent administering of other antigens and supplements during polio vaccination campaigns. For example, in 2012 82 million children were provided Vitamin A supplements, and it is estimated that somewhere between 1.1 and 5.4 million deaths will be prevented each year through this effort. Additionally, based on 2010 data on polio programs, 27 million children received measles vaccinations, 34 million children received deworming tablets, 4 million insecticide treated bed nets were distributed, 5 million children received tetanus toxoid injections, and 7 million children received yellow fever vaccinations. 98. More broadly, polio programmes have helped build up the capacity of weak health systems and contribute to the overall success of routine immunisation efforts. In Bihar, India, polio eradication activities have played, and continue to play a role in efforts to strengthen routine immunisation, including improvement of the cold chain, vaccine stock management and monitoring stock outs, identification of highrisk areas, registration of newborns, monitoring of RI sessions, micro-planning, social mobilization and more. RI coverage in Bihar increased from 18.6% in 2005 to 66.8% in 2010.64 The 2013-18 Strategic Plan places a strong emphasis on measureable activities to be supported by polio staff to strengthen routine immunisation efforts in targeted countries with the largest unimmunised and underimmunised populations. 99. As India has shown, programme effectiveness is also enhanced when endemic countries contribute funding to their own programme. In the past, polio-affected countries have provided annually, on average, over US$200 million (2006-2011) or approximately 25% of the GPEI budget. Today polio-affected countries continue to provide significant funding to tackle polio and have plans to do so in the future. In 64 Data in National Polio Surveillance Project (NPSP) 2010. 43 addition to their financial contributions towards the GPEI budget requirements, it is estimated that most polio-affected countries also make in-kind contributions through the time spent by volunteers, health workers and others in the planning and implementation of supplementary immunisation activities. These contributions are estimated to have a dollar value approximately equal to that of international financial contributions.65 100. Upfront commitments to GPEI for full funding give certainty and allow the programme to concentrate on rational planning of eradication activities instead of fund-raising or preparing for funding shortages. The assurance of funding also allows GPEI to execute the long-term components of the plan, including immunisation strengthening, instead of solely focusing on interrupting transmission. Thus, secure and predictable funding lends itself to greater programme effectiveness as well. E. Summary Value for Money Statement for the preferred option 101. Option 3 offers the optimum combination of predictable funding pooled with other donors’ funds, additional funding as a result of improved performance and increased commitments by other donors and targeted support to specific contextual challenges in remaining endemic countries. This will ensure a flexible, responsive and comprehensive programme. 102. The GPEI strategy represents a largely proven and WHO endorsed set of interventions with a strong evidence base and a track record of progress. Good evidence exists to support the cost effectiveness of individual components and an integrated set of interventions. The Strategic Plan is untested in places (particularly WHO/UNICEF management capacity) and will require strong and regular oversight, including remedial action where the need is identified. Alongside support to GPEI, the UK will influence dialogue and strategies taken by partners, and leverage its influence with endemic country governments by programming support to wider health services in polio affected communities through the third channel. Learning the lessons from Bihar in India, we will use the polio infrastructure to improve routine immunisation. It is recommended that the UK provides up to £300 m to support progress towards polio’s elimination and eradication, and the associated benefits. In doing so, this programme will make a considerable contribution to the UK Government’s commitment to combatting infectious disease. 65 http://www.polioeradication.org/Financing/Donorcontributions.aspx 44 Commercial Case Indirect procurement A. Why is the proposed funding mechanism/form of arrangement the right one for this intervention, with this development partner? 103. Most of the proposed programme does not require direct procurement by DFID. By continuing support to GPEI ,DFID works through existing partnerships with a proven track record of achievement. This minimises transaction costs and maximises economies of scale and opportunity costs. For third channel funds, appropriate contracting arrangements will be put in place depending on the type of programme and available partners. Their management and contracting arrangements will be made explicit in submissions seeking approval and through relevant business cases. 104. At the global level (channels one and two), DFID will fund GPEI through a standard model DFID Memorandum of Understanding (MOU) agreement with WHO. A budget has been drawn up to accompany the MOU. The use of indirect procurement proposed in this intervention will be managed through WHO and UNICEF procurement systems. 105. For the third channel, DFID will initiate research or respond to requests, for example proposals for conflict analysis, support to community mobilisation, RI or general health support. It will be important to work with partners who are not only well established and integrated with local systems but also to work with those who have the best information and understanding for influencing and supporting local communities. This may involve routing funds to GPEI ,UNICEF, or an NGO through an accountable grant, or an existing DFID, other donor or government programme. Proposals may be generated through an open call or a more limited or targeted request depending on the circumstances. At country level, the key challenges are constantly in flux, and similarly, the annual funding gaps at global level are unknown at this stage. Thus, DFID will retain flexibility in the proportion of funds routed each year through the global GPEI programme and through the third channel flexible country support window. Procurement generated by activity under the third channel will be governed by DFID procedures or the contracted organisation. B. Value for money through procurement 106. GPEI (WHO and UNICEF) procurement is managed through competitive procedures including limited international bidding and long term agreements. WHO undertakes a broader approach which includes planning, market research, competition on a wide geographical basis, consideration of good commercial practice and use of rigorous formal tendering procedures. Centralised procurement is used where appropriate. WHO procurement policy excludes any supplier with a direct or indirect connection with the sale or manufacture of anti-personnel mines or with child labour. Suppliers are requested to provide information on the environmental impact of their products. Where two offers are substantially alike, environmental factors may be decisive in awarding the bid. 107. In the DFID Multilateral Aid Review, WHO scored satisfactorily on procurement, concluding that the organisation’s approach to procurement is driven by value for money. The review found that WHO global procurement potentially drives down the global costs of medical supplies and drugs and contributes to financial efficiencies for 45 its recipient countries. For example by undertaking bulk procurement processes WHO was able to procure HIV test kits at about half the normal cost in the open market. 108. In the DFID Multilateral Aid Review, UNICEF scored strong on “Contribution to UK development objectives” and satisfactorily on “Organisational strengths”. Procurement was not reviewed explicitly but the review noted that UNICEF is taking positive steps to improve cost control, and has reduced its administration to programme cost ratio. 46 Financial Case A. What are the costs, how are they profiled and how will you ensure accurate forecasting? 109. The programme would span seven years (UK financial years 2013/14- 2019/20). From Year 2 the timing of funding will in-part be determined by negotiation of the challenge fund elements . The funding profile is described in table 5. 110. DFID will sign a new Memorandum of Understanding (MoU) with WHO which sets out in detail payment, accounting, reporting and audit requirements. DFID’s contribution will be paid in annual instalments, in accordance with the payments schedule in the MoU. GPEI will implement the programme, based on annual work programmes originating from the Strategy. WHO will submit requests for financing according to the terms of the Memorandum of Understanding (MoU). 111. The expenditure is coded on ARIES as 203826-101: Infectious disease control (100%). B. How will it be funded: capital/programme/admin? 112. This project will be funded from Programme funds, in budget centre PO 372. Requirements annually by funding type (£m) : 2013/14 = 100.25 2014/15 = 62 2015/16 = 45 2016/17 = 40 2017/18 = 35 2018/19 = 17.75 113. There are no contingent or actual liabilities. Payment timing across financial years will be forecast annually to meet DFID requirements. Human resources in DFID: 114. In order to achieve the potential impact of Option 3 (especially the third channel), it may be necessary to dedicate more skills and capacity to programme design, implementation and monitoring. At HQ level, there will be a single focal point for immunisation including polio eradication. Additional capacity in the DFID offices in Nigeria and Pakistan may be required to enable them to work up the best options for addressing critical constraints, negotiate these with country partners, support implementation and ensure rigorous monitoring and accountability. The budget for increasing front line development (FLD) staff, if needed would be met from third channel funding. C. How will funds be paid out? 115. Funds for channels one and two will be paid out according to the standard DFID/WHO MoU template. Funds for channel three will depend on the contractual relationship. Individual country proposals in this fund will set out arrangements for payments. 47 D. What is the assessment of financial risk and fraud? 116. To GPEI: Low. GPEI activities are implemented through GPEI core partner agencies, primarily WHO and UNICEF, in coordination with national governments, as well as through direct implementation by national governments themselves. WHO financial management and implementation is governed by WHO’s policies and procedures for Organization-wide Strategic Risk Management and the WHO Fraud Prevention Policy. Decisions regarding the use of financial and other resources through WHO will be taken by managers in the context of a strengthened organisation-wide risk management framework. This is supported by a sound internal control framework with a policy that deals with assessment of the risks of fraud, preventative measures that protect against fraud, and contingency measures that ensure that corrective action is taken to hold accountable those persons who are responsible for fraud. All WHO agreements and country-based financing arrangements will be governed by these policies and procedures will be developed based upon detailed budgets and workplans, and will include a focus on reporting and risk monitoring arrangements. 117. The GPEI Finance Working Group is responsible for management and oversight of the GPEI Financial Resource Requirements (FRRs), including ensuring cross agency alignment on GPEI requirements and financing needs, reporting to the Polio Steering Committee. Through the FRR update process (conducted every four months), the Finance Working Group ensures that cost control measures are applied during the budget development and revision process. During the second half of 2013, the Finance Working Group will engage in additional efforts to strengthen and standardise such measures, and to improve overall GPEI financial accountability. 118. Arrangements for the third funding channel will reflect those in place for bilateral programmes in that country or region. E. How will expenditure be monitored, reported, and accounted for? 119. Within DFID, overall the programme oversight will be handled by a health adviser and programme manager based in Human Development Department with additional and complementary engagement and oversight by country based polio and immunisation focal points in Nigeria and Pakistan. Regular dialogue on technical and oversight issues will be maintained through the UK’s active participation in the various WHO/ GPEI mechanisms, and thematic working groups. WHO-GPEI 120. WHO’s financial system provides transparency on utilisation of the funds. WHO is audited every 2 years by its External Auditor, which certifies financial statements to be presented to the World Health Assembly. All expenditures are recorded and monitored in the Global Management System (GMS). The income and expenditure recorded in respect of the contribution is included in the WHO financial reports submitted to the World Health Assembly on an annual basis. A final certified statement of income and expenditure will be provided by WHO, after settlement of all encumbrances for activities started by WHO prior to completion or early termination of the agreement. 121. As a condition of tranche release, DFID will receive an annual statement of account, set in the context of all contributions. This should show contributions by donor or other source of funding and expenditure by line item/ type of expenditure and by 48 country of spend. This reporting requirement will comprise a condition of funds release. Country based financing: 122. It is envisaged that the majority of the third channel funds will support suitable country programmes. However, Human Development Department may identify relevant investments that will support problem solving and risk management in endemic countries or outbreak countries that are best designed and managed from London and these should also be eligible for funding following the same design and approval process as other funds. 123. Third channel funds agreed for programming under Option 3.3 should be transferred to the relevant budget frameworks once approved. For country-based programmes, this will be the country framework. For HQ based work, it would most likely be Human Development Department. The approval process will follow the standard DFID pattern: a preliminary submission seeking approval for each project to be funded under third channel. On approval, a business case will be developed and agreed at delegated authority level by the relevant head of department and a no objection from the Head of Human Development. Monitoring and accountability will comply with standard DFID procedures, including due diligence. Management Case 49 A. What are the Management Arrangements for implementing the intervention? 124. For the first and second channel funds ( delivered through GPEI), funds will be passed to WHO headquarters to be disbursed by the GPEI for activities to be undertaken by HQ, regional and country offices. Funds will be managed according to WHO rules and procedures. WHO/UNICEF work very closely on polio eradication campaigns with Ministries of Health and other development partners in the affected countries. 125. WHO will report to DFID according to the terms and conditions set out in the MOU.GPEI produces an annual report on progress towards eradication. 126. For third channel funds, management will be through DFID country offices in relevant countries (mainly northern Nigeria and Pakistan), or Human Development Department where more appropriate (for example to address a multi-country constraint or risk, or an operational challenge in an outbreak country or region). Decisions will be taken about how funds are allocated according to the process in paras 65-68,122 and 123. The proposed management arrangements, possible additional human resources requirements and monitoring/ accountability mechanisms for third channel funds are set out in paras 105, and 114/ 115. 127. Projects agreed under the third channel funding mechanism will be approved case by case. The management arrangements, monitoring, audit, reporting etc will be set out in a business case prior to funds draw down. These business cases should be proportionate, and standard delegated authority rules would apply. For projects under £5m, the business case will be approved by the country head or relevant deputy director. 128. For business cases over £5m, a strategic case and information note will be submitted to the Secretary of State requesting approval to design and implement the programme. Once the Secretary of State approves, the business case will be developed and approved by the relevant delegated authority (country head or deputy director for under £20m). B. What are the risks and how these will be managed? Risks Conflict prevents access to populations needing vaccination Outbreaks overwhelm eradication efforts Third Channel funding mechanism is untested Probability (3 high, 1 low) 3 Impact (3 high, 1 low) 2 Mitigation strategy 2 1 2 1 Outbreaks can occur until eradication is achieved. A comprehensive emergency response is well tested and has successfully controlled even large outbreaks in the past. While the third channel funding mechanism is untested, the kinds of programmes expected to be supported in this mechanism are not. While the programmes risk not having the desired impact on improving polio vaccination uptake, they are unlikely to cause harm to polio Close engagement with governments and other relevant actors including faith leaders and other trusted organisations; conflict analysis; 50 eradication efforts. DFID will monitor both through the wider governance structures of WHO as well as through our oversight of this programme DFID will refine and monitor, with partners in-country. Fiduciary GPEI 1 3 Fiduciary Country level Insufficient commitment by countries to polio 2 2 2 3 Continued dialogue with governments Continued international advocacy DFID will review progress annually and withhold payment if there is insufficient progress. Insufficient funds 1 2 Distrust or Insufficient commitment by endemic communities 2 3 Continued advocacy both for national funds and for widening the donor base for support to polio. Challenge funds to GPEI GPEI to pursue through the Strategic Plan, adapting where required. Community public health grants allocated if performance triggers met or allocated first, in order to meet the performance objectives and garner commitment? 129. Some of the main risks have been identified through the Programme Completion Report (PCR) for the previous period of UK support to polio eradication. Mitigation of these risks has been incorporated into the design of this programme. Examples include: the third channel of funding which seeks to reduce the risk of polio campaigns detracting from routine immunisation systems and reduce the risk of polio becoming an entrenched source of conflict; the insistence on an annual review of the strategic plan and; the extension of the challenge fund mechanism to include performance criteria. C. What conditions apply (for financial aid only)? n/a D. How will progress and results be monitored, measured and evaluated? First and second channel funding: 130. The contribution will be used for the purposes indicated in the MoU and administered in accordance with WHO Financial Regulations and Rules. Under this agreement, 7% of expenditure will be deducted by WHO to cover administrative costs in accordance with World Health Assembly Resolution WHA 34.17. Any interest earned on the cash balance of the contribution shall be used in accordance with WHO Financial Regulations and Rules. 131. Audit: All contributions to GPEI are subject to WHO internal and external auditing procedures. The External Auditor's certification of accounts and audit report is made available to the World Health Assembly on a biennial basis and sent to DFID. 132. GPEI will convene an annual review of progress against objectives and milestones, including the PPG. There will be quarterly monitoring of each Objective. The four Strategic Plan Objectives are monitored by 51 The Independent Monitoring Board (IMB) SAGE The Global Commission for Certification and Regional Certification Commissions WHO ( to be confirmed) 133. Technical assessment of GPEI is provided by the IMB, which monitors progress towards eradication. Established in response to donor group demand following the 2009 evaluation, the IMB has met quarterly since December 2010 to provide a regular and independent evaluation of progress towards each of the major milestones of the Global Polio Eradication Initiative (GPEI) Strategic Plan on the basis of polio epidemiology, poliovirus virology, standard performance indicators and other programme data. Additionally, the IMB provides assessments of the risks posed by governance weakness and existing funding gaps. When the IMB conclude that a milestone or process indicator is 'at risk' or 'missed', the relevant national authorities and/or implementing/donor partners are engaged to establish immediate corrective action plans. At subsequent meetings, the IMB then evaluate the quality, implementation and impact of any such corrective action plans. The IMB is comprised of global experts from a variety of fields relevant to the work of the GPEI, and was established at the request of the Executive Board (EB) and the World Health Assembly (WHA). Reports from the Board's quarterly meetings go directly to the heads of the spearheading partner agencies - WHO, Rotary International, the US CDC and UNICEF, the Bill and Melinda Gates Foundation and are made public shortly afterwards. 134. The SAGE which is the principal advisory group to WHO for vaccines and immunisations is providing guidance on the introduction of IPV. GPEI will work with GAVI on this. 135. GPEI is overseen by the Polio Oversight Board, consisting of the heads of 5 agencies: WHO, UNICEF, CDC, Rotary, and BMGF. The Polio Partners' Group is a larger, more inclusive oversight body, encompassing senior representatives from donor/prospective donor agencies, foundations, NGOs, polio-affected countries, and Steering Committee agencies. The Partners Group holds ad hoc conference calls and meets every six months in the margins of SAGE meetings to facilitate participation in SAGE strategy deliberations. Among other objectives, the Partners Group endorses workplans and budgets developed by countries for Steering Committee, undertakes diplomatic and advocacy interventions to mitigate risks, and provided input into Polio Endgame plan and financing. 136. GPEI will provide regular technical reports to stakeholders including DFID over the Programme period, including annual progress reports, annual reviews and a final report at the end of the funding period. These reports will trace progress at global and country level. GPEI will provide DFID offices with country reporting in the same fashion. DFID does not plan a separate evaluation as GPEI is regularly the subject of academic and technical studies. 137. Financial: The income and expenditure recorded in respect of the contribution is indicated in WHO (the host organisation) Financial Reports submitted to the World Health Assembly on an annual and biennial basis. Certified financial statements of income and expenditure shall be provided to DFID after programme completion. A final certified statement of income and expenditure will be provided by WHO after settlement of all obligations for activities started by GPEI prior to completion or early 52 termination of the Agreement. 138. Monitoring and reporting: WHO will monitor risk and progress and report against the joint objectives framework throughout the programme. WHO collects immunisation coverage data at national and global levels in collaboration with national governments and GPEI partners. 139. Activities are monitored and evaluated (M&E) through GPEI’s standard set of internationally accepted process and outcome indicators for monitoring the performance and quality of country-level polio eradication activities. Surveillance and laboratory indicators for all regions and countries are updated biweekly on the Polio Eradication website and published quarterly by WHO. Detailed progress on all indicators including SIA coverage data is reported annually in the GPEI Progress Report. 140. WHO and partners will ensure that polio activities are included in routine monitoring systems and systems for review of health sector performance as a whole (joint annual reviews etc.), and that they are reported to health sector coordination mechanisms. The GPEI exit strategy should include plans for integrating parallel bodies such as the Technical advisory Group (TAG) back into routine country systems. Third channel funding: 141. A mid-term review (MTR) of DFID support will be carried out in FY 2015/16. Its scope will include decisions on the allocation of any residual balance of the third channel budget. Impact of the possible research, projects and programmes funded under this channel will be monitored and reviewed against their logframe indicators,as part of the MTR. Logframe Quest No of logframe for this intervention: to be added 53