Governance and Institutional Issues in COVID-19 Vaccination May 2021 Governance and Institutional Issues in COVID-19 Vaccination 1 1. COVID-19 Vaccination Differs from other Large-Scale Public Sector Activities Success in the roll out of the COVID-19 vaccination program requires that large numbers of people get the vaccine, quickly, equitably, and effectively. Importantly, this involves both the willing participation of the population and well-functioning government administration of the program. In this environment, the overall government vaccine program efficiency and effectiveness will depend on citizens’ trust in the vaccine efficacy as well as in government’s approach to vaccination. The purpose of this note is to summarize some of the key governance and institutional issues surrounding rapid universal vaccination. 2. Key Risk Areas Risks can be grouped into five key areas: contracting, physical distribution, vaccine integrity, equity, and misinformation.  Contracting: The contracts for the purchase of vaccines from manufacturers have received considerable attention, notably over the lack of transparency in pricing and other terms of the contracts. The limited transparency—contracts are typically heavily redacted—could increase risks of corruption or waste, and even in the absence of corruption could lead to loss of trust. The vaccine contracts are still largely done in a sellers’ market, driven by the huge demand and need for universal coverage in the face of supply limitations. The multiple sources of financing involved coupled with requirements relating to each financing entity (donor, government, level of government, etc.), further complicates the contracting 1 This note is one of a series on “Governance & Institutions: COVID-19 Response Resources,” prepared under the guidance of Ed Olowo-Okere, Global Director. The development of this note is overseen by Adenike Oyeyiola and Tracey Lane, Practice Managers. Preparation of the note was led by Srinivas Gurazada and James Anderson, with inputs from Jiwanka Wickramasinghe, Rajat Narula, Rima Koteiche, David Bernstein, Francesca Recanatini, Craig Hammer, Hunt La Cascia, Iwona Warzecha, Patrick Umah Tete, Fernanda Balduino, Khuram Farooq, Hunt La Cascia, Steven Davenport, Serdar Yilmaz, Saidu Dani Goje, and Katherine Siess. The note benefitted from the insightful comments from Seemeen Saadat and Sameera Maziad Al Tuwaijri from the Health, Nutrition and Population Global Practice with guidance from Muhammed Ali Pate, Global Director, and Feng Zhao, Practice Manager. Governance and Institutional Issues in COVID-19 Vaccination 1 process. Timely initiatives, such as the COVAX facility, can help mitigate key risks relating to equity and fair distribution while emphasizing quality. However, the unprecedented global demand, which is only partially met by the COVAX facility, still leaves governments navigating complex contracting issues.  Physical Distribution: The manufacturing process has numerous supply chain complexities. For most developing countries, supply chain complexity begins in the receipt and distribution of the manufactured vaccine. Where vaccines are imported, customs clearance processes (and facilities) are only the first stage. The supply chain from point of origin to regional hubs to distribution centers requires networks of refrigerated transportation, cold storage facilities, dry ice, and more. The distribution process also calls for appropriate levels and location of vaccine-related supplies such as syringes. This process allows many opportunities for leakage or spoilage and for fraud and corruption. In addition, the public administration challenges are immense, given the need to mobilize and deploy skilled people, sometimes across large geographical areas, organize facilities, keep track of progress according to prioritized groups, and so forth. The structure of governance (centralized or decentralized institutions) and related maturity of institutions in both public and private sectors can facilitate or hinder the process. Distribution that relies entirely on decentralized systems and implementation, with little central coordination, can add complexity and confusion. In addition, power imbalances combined with limited supplies of vaccines can increase the risks of violence, especially gender-based violence.  Vaccine Integrity: The risk of fraudulent or counterfeit vaccines cannot be overestimated, particularly when the momentum of vaccination significantly ramps up. This has multiple potential negative impacts. In addition to waste, there are risks that people think they are immune while receiving a counterfeit (and therefore ineffective) vaccine, increasing the spread of the disease. Also, there is the risk that fraudulent vaccines will cause the population to doubt the vaccine program and avoid getting vaccinated. Further, the preference for a specific vaccine over others that are equally recommended, sometimes fueled by misinformation as described below, adds to the risks relating to vaccine integrity.  Equity: Perceptions of inequitable distribution of vaccines can have devastating effects, ranging from attempts to obtain vaccines through illegitimate means to social unrest. Decisions on prioritization could be undermined by favoritism or corruption, undermining trust in the system, costing time and money, and leading to a slower rollout of the vaccine. Transparency over who is eligible and when, and the rationale for prioritization among groups as well as strict compliance in implementation helps build trust in the equity of the process. Equity considerations Governance and Institutional Issues in COVID-19 Vaccination 2 will play a role at both the planning and contracting stages since vaccine purchasing contracts need to consider distribution plans.  Misinformation: Even if the government controls the four governance risks outlined above, there is still the risk that misinformation could undermine the success of the program. The misinformation could include rumors about side effects or efficacy of the vaccines, confusion about where and when to receive the vaccines, etc. Given the shelf life and risks of spoilage, delays generated by such misinformation could be costly. Rumors spreading over social media are a major area of concern. 3. Governance Tools for Managing the Risks The risks outlined above are fundamentally governance risks and many have already become realities during the global vaccine rollouts. Managing the risks must be done in a way that is consistent with the objective of rapid, equitable, rollout with minimal loss or waste. Transparency and Planning for Equity A key risk in COVID-19 vaccination is that the vaccines may not reach the most vulnerable sections of the population and instead get diverted to elites and their families. The loss of trust from such diversion could undermine the effort and potentially lead to civil unrest, as we have already seen in some places. Establishing and publicizing clear country-determined criteria for vaccine distribution and administration, with mandated and detailed record-keeping, and transparency on how the government is complying with the published criteria can help minimize this risk. In most countries, the vaccines are likely to be provided in a phased manner with the most vulnerable people prioritized. Rolling out a registration system and updating records ahead of the deployment can help ensure that it is clear which category of people (front line workers, the elderly, those with medical conditions, the general population, and so on) will receive vaccinations and when. This can be especially challenging in countries with incomplete or nondigital registration systems. Indeed, the most vulnerable groups are often precisely those omitted from the databases. It is also important that criteria are open to public so that citizens can check if the criteria for the distribution are being followed. Local governments can be instrumental in identifying the highest priority population groups for the vaccines and can help implement criteria for different phases of prioritization. The definitions of vulnerable groups may vary from country to country. In the context of the pandemic, vulnerability refers those most at risk from the disease, and those who may Governance and Institutional Issues in COVID-19 Vaccination 3 not have easy access to services or to economic opportunities. Temporary workers, migrants, or people with informal jobs or seasonal jobs may be vulnerable and need special targeting efforts. Refugees, internally displaced persons, non-citizens, and others may also be vulnerable, depending on the country. In addition, since the purpose is to stop or slow the transmission of the disease, workers in certain occupations that are both high-risk and important in terms of controlling the spread may also be prioritized. Accessibility to centers where the vaccines will be administered is very important, especially to vulnerable groups. Where possible, private sector data, open data, and crowdsourcing platforms can be used to help inform decisions about where to place COVID-19 vaccine administration centers in order to maximize reach to vulnerable populations, efficiently and quickly. A good communications strategy can help fight against vaccine hesitancy by raising awareness and educating communities about the benefits of vaccines and the continuing need for social distancing, masks, etc. Local government officials—including elected local officials as well as teachers, police officers, community health workers, local community leaders like religious ones, market directors and local administrators—are the public officials that citizens most often interact with directly and are typically the most trusted. As such, these local governments can play an important role in maintaining ongoing communications with community leaders and other stakeholders, in some cases in local languages, to ensure consistent messaging. The importance of planning for the physical rollout of the vaccination program cannot be overestimated. A study of country readiness for COVID-19 vaccines carried out by the World Bank revealed that 85% of countries have developed national vaccination plans and 68% have vaccine safety systems, while only 30% have developed processes to train the large number of vaccinators who will be needed for the campaign. 2 An even smaller fraction of countries (27%) have created social mobilization and public engagement strategies to encourage people to get vaccinated. Contracting, Openly and Efficiently The risks of corruption in health sector procurements were well acknowledged even before COVID-19. Vaccine procurement and contract management are subject to additional vulnerabilities and risks. Procurement risks include collusion between bidders, non-compliance with contract conditions, invoicing for wrong quantities, duplicate 2 Assessing Country Readiness for Covid-19 Vaccines: First Insights from the Assessment Rollout. World Bank. March 2021. The country readiness assessments for COVID-19 vaccines are undertaken jointly by governments; the World Bank; Gavi, the Global Vaccine Alliance; the Global Fund to Fight AIDS, Malaria and Tuberculosis; UNICEF and the World Health Organization. This report presents initial findings of 128 countries as of March 2021. Governance and Institutional Issues in COVID-19 Vaccination 4 invoicing, falsification of stock receipts, and bribery to receive payments on invoices out of queue, among others. Contracting openly and transparently can help mitigate these risks. In addition, efforts to reward transparency from producers and distributors of vaccines can incentivize positive behavior. With countries having to use local private sector for vaccine delivery, it is even more imperative to strengthen the regulatory environment to prevent fraud and scams and to ensure quality and integrity of vaccines. Greater citizen engagement through making contract information available to the public, introducing citizen complaint mechanisms, and launching communication campaigns can minimize misinformation, pilferage, diversion, and other risks. In some countries, in view of complexity of vaccination procurement and delivery systems, governments may be using procurement agents for managing procurement, distribution, logistics and warehousing, campaign planning, mobilizing the workforce, and tracking the delivery and administration of vaccines. While this practice brings additional professional support to countries with weak capacity, they carry their own risks relating to procurement of such agency contracts, and the risks of vested interests or bias of the procurement agent, that should be mitigated through enhanced oversight and transparency. Public Financial Management Systems as Enablers of Timely and Effective Administration of Vaccines Weaknesses in Public Financial Management (PFM) systems can also significantly affect COVID19 procurement and distribution. The 2020 Global Report on Public Financial Management issued by Public Expenditure and Financial Accountability (PEFA) Secretariat identifies several limitations of PFM systems in developing countries. Effective vaccine distribution needs appropriate PFM systems in place, particularly where vaccines are procured through budget processes and treasury systems (as opposed to direct supplies by external development partners). This requires ensuring adequate budget provisions for vaccine payments. In case budgets are not directly allocated for vaccines, systems may be put in place to ensure virement or supplementary allocations expeditiously. The budget process may include a provision to manage indemnity provisions of the contract to help manage risks. For efficient vaccine management, internal control procedures for supply chain and inventory management processes should be aligned with the speed and flexibility required for vaccines, as well as procedures on physical control and safety of the drugs. Contract payments need liquidity so disbursement procedures (advances, direct payments, etc.) need to be in place, either based on pre-existing standard systems or as emergency procedures. A quick review of funding sources to assess the degree of harmonization and Governance and Institutional Issues in COVID-19 Vaccination 5 alignment with the requirements of vaccine distribution could help optimize the impact of cash flows and reduce the risk of bottlenecks caused by illiquidity. The transparency efforts described earlier should work in concert with the financial management reporting and accountability system. Publishing regular financial reports on vaccine purchases and distribution can be done through collaborative efforts of Accountant General (or equivalent) with the Ministry of Health and other agencies. Internal audit helps ensure that the plans of the government on vaccine deployment are effectively implemented. One useful tool of internal audit is the “Just-in-Time” compliance audit, covering supply chain, payment processes, facility-level service delivery, administration of the vaccines, etc. Also, payment certification processes by internal auditors that ensure proper accountability on the authenticity of the vaccines and their related payments can boost the credibility of the process. Ideally, each country would put in place an internal control framework for the vaccine logistics and management systems. Essential areas where appropriate controls should be established include the receipt and issuance of the vaccines in/out of the medical (central) stores, logistics and transportation of the vaccines to facilities in country, and receipt and the actual inoculations at facility/inoculation centers. A third-party monitoring approach and even ‘whistle blower’ arrangements could be useful mechanisms, particularly in low capacity and weak governance environments. Monitoring and Technology for Controlling Risks in the Physical Distribution of Vaccines Capacity constraints may pose formidable challenges to the timely distribution of vaccines to different geographical areas. The logistics of the distribution arrangements need to be reviewed, discussed, and agreed as a part of the planning, continuous monitoring, and correction process. In those places without a centralized national health care system, distribution and administration of vaccines could include a large role for private sector companies, pharmacies, and doctors. Where possible, automated systems for real-time monitoring and capturing of information (e.g., bar coding, geo tracking systems, connections to COVID Vaccine trackers) can facilitate the process, and these systems can be facilitated by the use of smart phones that can scan and transmit data. Establishing a process of management reports (including exception reports) can help monitor vaccine stocks on a real-time basis. With few countries opening up direct contracting by private health facilities with vaccine producers, the use of technology for integrating the data on regional distribution of vaccines as well as different segments of the population to be vaccinated will be facilitated by technology. At the same time, the digital divide, which is Governance and Institutional Issues in COVID-19 Vaccination 6 particularly acute in remote and hard to reach areas and in FCV settings, suggest the need to ensure that technology-based approaches are not relied upon exclusively. Given the scarcity of the vaccines in relation to demand, there is a risk that the vaccines could be pilfered, diverted, or wasted. There could also be exploitation by some health care workers trying to make money by administering vaccines privately to individuals outside the regular process. Wastage of vaccines may not necessarily be driven by bad intentions, but can result from poor planning and distribution systems that allow doses to go unused before expiration, for example when a box is opened without sufficient immediate demand or an information system to alert people to the opportunity to receive a dose. The arrangements for procurement and storage of the vaccines should be sound – so that there is no possibility of leakage of vaccines. There needs to be a clear designation of which body is responsible for monitoring the usage of the vaccines; where possible, a national institutional mechanism should oversee this task. Technology can help reduce risks, for example equipping vaccines boxes with sensors that enable tracing of the physical location of the vaccines. Use of geotagging on movement of the vaccines and their actual use could strengthen the physical controls over the vaccines and mitigate the risk of misuse and leakages. Establishing clear guidelines and adequate approvals at various points of vaccine movement can reduce confusion and strengthen confidence that vaccines are not diverted. Vaccine trackers can help collect data on inoculations including detailed citizen information to track progress toward equity goals. Interfacing these with supply chain data will provide information on possible leakages. Random checks by Ministry of Health officials, internal auditors, and other teams to the health centers administering the vaccines can reduce the risks of diversion. Government Oversight for Efficiency and Accountability To ensure a smoothly operating accountability framework, a country’s Supreme Audit Institution (SAI) should be informed of all policy actions and plans relating to vaccines. With independence protected through constitutional or legal structures, SAIs are positioned to play a critical role in the accountability chain. In jurisdictions where the SAI is mandated to conduct pre-audit reviews, vaccine procurement could be prioritized for such reviews. In most cases, the SAI mandate covers audit of procurement, deployment, and overall performance of government on vaccine administration, compared to established practices. By prioritizing such audits, SAIs’ audit recommendations can help governments to make course corrections that will enhance citizen’s trust in government and contribute to the success of the program. SAIs may specifically consider a rapid performance review of vaccine administration processes from a service delivery perspective. Governance and Institutional Issues in COVID-19 Vaccination 7 Considering the speed of actions taken by governments and, in some places, lowering of traditional financial and other controls, the perceptions of increased corruption can multiply quickly. To reduce corruption risks, and the risk of increased perceptions of corruption, oversight agencies such as SAIs and anticorruption authorities should take a coordinated and transparent approach to their prevention and investigative efforts and communications strategies. The oversight mechanism should include candid assessment of appropriateness of messaging across various governmental actions. For example, any VIP treatment provided for powerful political players (like vaccination of elected and public officials outside the approved priority list), could send the wrong message to citizens. There are already news reports from many countries to this effect. Furthermore, oversight authorities may actively focus their attention on misuse of information about the vaccine and its distribution for personal reasons and interests by key players in the vaccine deployment. Role of Subnational Governments Local Governments can play a key role not only in administration of vaccination, but also in ensuring accountability. In countries where local governments are responsible for primary healthcare service delivery, locally run clinics or community health centers are the first point of contact for citizens, especially in rural areas. Local governments can provide direct support to vaccination programs by offering vaccines in these facilities. Even in countries where local governments do not have primary responsibility for local health service delivery, their resources can be used to support vaccination programs: providing transportation to vaccine sites and providing support for medical staff within their locality. As noted earlier, distribution processes that rely on each subnational government to establish its own system increases complexity and associated risks. Subnational government play an essential role in distribution, but central governments can help reduce complexity by harmonizing systems across subnational governments. Citizen and Civil Society Oversight Providing regularly updated and credible data on vaccination rates helps support transparency and citizen oversight—establishing citizen feedback channels at various stages makes this system even stronger. Formal involvement of civil society organizations (CSOs) such as medical associations, local welfare organizations, watchdog entities, faith-based organizations, etc., can help build trust. In some cases, governments (or development partners in consultation with governments) could fund CSOs to provide oversight and feedback on the progress in appropriate targeting and administration of vaccines as well as the related expenditure. Local communities need to be encouraged to advertise statistics such as the daily number of doses received, administered, wasted, etc. Disaggregation of vaccines administered based on gender, income, community, etc., would help timely Governance and Institutional Issues in COVID-19 Vaccination 8 actions for enhanced equity in vaccine administration. CSOs can also be valuable partners in expanding accessibility since some people cannot afford to stay in physical queues for long due to physical ailments or for fear of loss of wages. Role of Donors and International Agencies Development partners and international agencies play a pivotal role in ensuring that vaccines reach the arms of the poorest in the remotest locations of the world. Further, the initial trends of high-income countries purchasing the majority of doses of vaccines, creates risks of developing countries falling significantly behind. Equity in vaccination is not only an issue across groups within a country, but across countries of the world— development partners have a key role in supporting equitable distribution. Further, in many countries, the multiplicity of agencies involved in vaccine distribution complicates matters. Where procurement of the vaccines involves international organizations such as WHO or UNICEF, the issues relating to the coordination with and accountability of such agencies becomes critical. The efforts of Government, partnerships like COVAX, development partners like World Bank and all other stakeholders needs to be well coordinated using an efficient, evidence-based, and timely information and reporting system. Selected Resources Helene Barroy, Srinivas Gurazada, Moritz Piatti-Fünfkirchen, and Joseph Kutzin (2020). “No storm after Calm: Need to retool PFM system in health sector” P4H Social Health Protection Network, May 1, 2020. (Link) Liz Dávid-Barrett (2020). “Let’s make sure corruption does not de-rail the vaccine rollout!” Centre for the Study of Corruption, University of Sussex. December 17, 2020. (Link) Hélène Barroy, Federica Margini, Triin Habicht, Tomas Roubal, Peter Cowley, and Joseph Kutzin (2021). Why PFM is Key for the Effective Roll Out of COVID-19 Vaccines. IMF Public Financial Management Blog. (Link) Jared S. Hopkins and José de Córdoba (2021). “Pfizer Identifies Fake Covid-19 Shots Abroad as Criminals Exploit Vaccine Demand.” The Wall Street Journal. April 21, 2021. (Link) IATA (2021). “Guidance for Vaccine and Pharmaceutical Logistics and Distribution Set of considerations and awareness on large scale handling, transport and distribution of Governance and Institutional Issues in COVID-19 Vaccination 9 vaccines, pharmaceutical, life science and medical products.” Edition 4 – 30 March 2021. (Link) Zachary Meskell (2020). “Corruption and the COVID-19 Vaccine: The Looming Problem of Distribution” Global Anticorruption Blog, October 26, 2020. (Link) Bruno Sanchez-Andrade Nuno and Holly Krambeck (2020). “Facebook, Mapbox: Addressing COVID-19 through Public-Private Data Partnerships -- Where Do We Put New Testing Facilities?” Development Data Partnership. (Link) PEFA (2021). 2020 Global Report on Public Financial Management. PEFA Secretariat. (Link) Kaunain Rahman (2021). “Mitigating Corruption Risks in COVID-19 vaccine rollout: What can donors do?” U4 Helpdesk Answer. (Link) Natalie Rhodes (2021). “Will COVID-19 be the Shot in the Arm that Improves Pharmaceutical Pricing Transparency?” Transparency International. January 21, 2021. (Link) Kristen Robinson (2021), “8 Reasons Why Vaccine Procurement Should be Open.” February 25, 2021. (Link) UN Committee on Migrant Workers (2021). “Joint Guidance Note on Equitable Access to COVID-19 Vaccines for All Migrants.” (Link) UNODC (2020). COVID-19 Vaccines and Corruption Risks: Preventing Corruption in The Manufacture, Allocation and Distribution of Vaccines. (Link) Aime Williams (2021). “The US spat over the vaccine IP waiver” The Financial Times. April 21, 2021. (Link) World Bank. Governance & Institutions COVID-19 Response Resources. https://www.worldbank.org/en/topic/governance/brief/governance-institutions-covid- 19-response-resources Select news stories related to vaccine distribution: Argentina. Lebanon. Malawi. Moldova. Pakistan. Peru. Philippines. Spain. Uganda. Cover photo: COVID-19 testing, Madagascar. March 31, 2020. World Bank / Henitsoa Rafalia. https://www.flickr.com/photos/worldbank/49833709508/in/album- 72157714093198703/ (CC BY-NC-ND 2.0) Governance and Institutional Issues in COVID-19 Vaccination 10