The World Bank Moldova Emergency COVID-19 Response Project - Additional Financing (P175816) Additional Financing Appraisal Environmental and Social Review Summary Appraisal Stage (AF ESRS Appraisal Stage) Public Disclosure Date Prepared/Updated: 02/09/2021 | Report No: ESRSAFA089 Feb 16, 2021 Page 1 of 17 The World Bank Moldova Emergency COVID-19 Response Project - Additional Financing (P175816) BASIC INFORMATION A. Basic Project Data Country Region Borrower(s) Implementing Agency(ies) Moldova EUROPE AND CENTRAL ASIA Republic of Moldova Ministry of Health, Labor and Social Protection Project ID Project Name P175816 Moldova Emergency COVID-19 Response Project - Additional Financing Parent Project ID (if any) Parent Project Name P173776 Moldova Emergency COVID-19 Response Project Practice Area (Lead) Financing Instrument Estimated Appraisal Date Estimated Board Date Health, Nutrition & Investment Project 1/29/2021 3/26/2021 Population Financing Public Disclosure Proposed Development Objective The objectives of the Project are to prevent, detect and respond to the threat posed by the COVID-19 pandemic in Republic of Moldova. Financing (in USD Million) Amount Current Financing 0.00 Proposed Additional Financing 0.00 Total Proposed Financing 0.00 B. Is the project being prepared in a Situation of Urgent Need of Assistance or Capacity Constraints, as per Bank IPF Policy, para. 12? Yes C. Summary Description of Proposed Project [including overview of Country, Sectoral & Institutional Contexts and Relationship to CPF] The Moldova Emergency COVID-19 Project (parent project) supports the Government of Moldova (GoM) in responding to a potential outbreak of COVID-19. Component 1 – Emergency COVID-19 Response – provides Feb 16, 2021 Page 2 of 17 The World Bank Moldova Emergency COVID-19 Response Project - Additional Financing (P175816) immediate support to respond to the COVID-19 outbreak, with a focus on limiting community transmission, building capacity to handle severe cases, and mitigating the negative financial situation at the household level. It also supports the development of multisectoral response coordination and community preparedness. Additionally, Component 1 supports social assistance efforts to mitigate the effect of containment measures on the poor. Component 2 – Implementation management and monitoring and evaluation – finances the project management unit and monitoring activities. The proposed Additional Financing (AF) will fill a critical gap in the scope of the parent project by providing funding for the procurement and deployment of safe and effective COVID-19 vaccines, including vaccine-related communication activities, planning and management, supply and distribution, and digital health information. Under Subcomponent 1.5 (Vaccine Procurement and Deployment), the AF will finance the procurement of vaccines, from COVAX (through UNICEF as procurement agent), manufacturers, or other countries, in the three stages of vaccine deployment, where these are determined to be eligible for Bank financing. The AF will also support vaccination planning and management by financing technical assistance, including from UNICEF and the World Health Organization (WHO), to establish institutional arrangements, develop regulations, and specify standard operating procedures, including for informed consent, pharmacovigilance, indemnification of manufacturers, and social engagement and mobilization (including community outreach activities). Planning for new investments in cold chain infrastructure will prioritize procurement of highly energy-efficient equipment. Activities under Sub-Component 1.5 will leverage the opportunity to invest in sustainable, climate-friendly, energy-efficient cold chain infrastructure, including for transportation, minor works and storage equipment. This would be the second AF Public Disclosure to this project; the first AF was approved on December 23, 2020. D. Environmental and Social Overview D.1. Detailed project location(s) and salient physical characteristics relevant to the E&S assessment [geographic, environmental, social] As with the original Moldova Emergency COVID-19 Project (the Project), the Additional Financing (AF) has the same E&S baseline and country-wide coverage. Moldova is located in south-eastern Europe, between Ukraine and Romania, has a surface area of 33,850 square kilometers and with an estimated population of approximately 3.5 million people (WDI, 2018). The surface area is roughly divided in 91 percent rural and 9 percent urban. Agricultural land use covers about 75 percent of Moldova’s total land area. Administratively, Moldova is divided into 32 districts (rayons), three municipalities and two autonomous regions—Gagauzia and Transnistria. Moldova is vulnerable to changes in external demand and climate shocks due to its small size, open economy, and reliance on agriculture. In the COVID-19 context, Moldova’s poor systems for medical waste management and disposal and lack of adequate and appropriate water supply and sanitation conditions, especially in the rural areas, make the country highly vulnerable. At effectiveness in May 2020, the Project had not completed some E&S requirements, including preparation of the Environmental and Social Management Framework (ESMF) and staffing the PIU with E&S specialists. These two requirements were met by September 2020. In the first eight months of implementation, critical procurement activities were carried out, with 35 contracts for different equipment, supplies, and personal protective equipment (PPE) signed and delivered under Subcomponent 1.1 and 1.2. Social assistance activities under the Project supported Feb 16, 2021 Page 3 of 17 The World Bank Moldova Emergency COVID-19 Response Project - Additional Financing (P175816) by performance-based conditions have enabled transfers to over 54,000 poor households. Furthermore, the Project developed a communication and awareness campaign focused on the safety measures required to minimize the spread of the virus. The campaign included the development of video clips to be aired on national television; audio messages on safety measures broadcast in malls, shops, marketplaces, and on public transportation; and adverts placed on Facebook and LED billboards. The Project and this AF, will provide immediate support to respond to the COVID-19 outbreak, in particular to limit local transmission through containment strategies, appropriate infection prevention and control (IPC) and intensive care to patients suffering from severe acute respiratory infection. The primary objectives of this AF are to enable affordable and equitable access to COVID vaccines, and to help ensure effective vaccine deployment in the Republic of Moldova through enhanced vaccination system strengthening. Moldova developed and released in January 2021 a National COVID-19 Vaccination Plan, clarifying the essential steps for implementation of the national vaccination campaign such as planning and management, service delivery, logistics and cold chain, and supporting systems. The National Immunization Technical Advisory Group (NITAG) is the overall governing body for national vaccination programs, including the COVID-19 vaccination campaign. NITAG is advised by the National Technical Working Group (NTWG) which will support program implementation, and which includes representatives from the NAPH, Ministry of Health, Labor, and Social Protection (MoHLSP), the Project Implementation Unit (PIU), and development partners, including the WHO, UNICEF, Gavi, the Vaccine Alliance, the COVAX Facility, and the Global Fund. Expedited regulatory pathways are in place to ensure emergency approval of COVID-19 vaccines within 14 working days of submission of an application and to issue import authorization for COVID-19 vaccines in four working days. These approvals will be Public Disclosure undertaken by the Agency of Medicines and Medical Devices (AMMD), based on prior authorization by the WHO and Stringent Regulatory Authorities (SRAs). The Project AF activities will be national in scope, and will fill the critical gap in the parent Project, by providing funding for the procurement and deployment of safe and effective COVID-19 vaccines, including vaccine-related communication activity, planning and management, supply and distribution, and digital health information and other supporting systems. The broader COVID-19 response activities supported by the parent project, such as strengthening of laboratories and intensive care units (ICUs), quarantine and isolation centers, and the vaccination process may have considerable environmental and social impacts such as those related to medical and general waste disposal and concerns regarding social inclusion. The Project has helped close a gap in Government funding to prepare and respond to the pandemic, ensuring the availability of equipment to contain the spread of diseases and provision of necessary and timely treatment. This support has facilitated better organization of health services during the pandemic, and mitigation of environmental, sanitary, health and occupational risks at all stages of the process of identifying and treating diseases. This AF is being proposed at a crucial juncture in the Government of Moldova’s response to COVID-19. An important change in the state of science has been the emergence of new therapies and the potential production of COVID-19 vaccines. In addition to new therapeutics, promising COVID-19 vaccines are being developed. Twenty are in large- scale Phase III clinical trials. Recently published results from the trials of three vaccines show that they are safe and effective. The Pfizer-BioNTech COVID-19 vaccine has received emergency use authorization from a stringent regulatory authority. There are other pharmaceutical companies that have expressed confidence that they will soon have sufficient data from Phase III trials to apply for stringent regulatory authority approval. Global production capacity is also being developed, and COVID-19 vaccination commenced in high-income countries in December 2020. Feb 16, 2021 Page 4 of 17 The World Bank Moldova Emergency COVID-19 Response Project - Additional Financing (P175816) D. 2. Borrower’s Institutional Capacity As with the parent project, the AF will be implemented by the Ministry of Health, Labor and Social Protection (MoHLSP), primarily through the PIU. The MoHLSP and the PIU have experience in managing environmental and social risks associated with World Bank projects such as the ongoing Program-for-Results (PforR) project, “Health Transformation Operation,” (HTO, P144892) and the parent project. Though their experience is primarily with the World Bank’s Safeguards Operational Policies rather than the Environment and Social Framework (ESF), the PIU has prepared an Environmental and Social Management Framework (ESMF) for the parent project. The country also has an appropriate legal framework and established institutions for environmental and social risk management. The MoHLSP, in which the PIU is situated, has full responsibility for the organization and regulation of health services provided to the public and for ensuring the state surveillance of population health. Financing of most health services is the responsibility of the National Health Insurance Company (CNAM). The MoHLSP has established the legal framework for the management and proper disposal of medical waste generated in the public and private health service sector. The MoHLSP develops and approves sanitary norms, rules, and hygienic specifications. MoHLSP will be the implementing agency for the project. It is designated as the central operational body within the GoM and standing headquarters for COVID-19 prevention and response. While the MoHLSP is the implementing agency of the project, the day-to-day project operations will be performed by the PIU, within the MoHLSP. As per the Project's Environmental and Social Commitment Plan (ESCP), the PIU has one Public Disclosure environmental specialist and one social specialist in the PIU. Considering the initial delays in preparing the ESMF, the Borrower will supplement the PIU's capacity to support implementation of the national vaccination campaign by hiring additional consultants to work alongside the E&S specialists, to support relevant activities, including the public outreach and communications campaign and medical waste management. The PIU will continue to be responsible for the parent project and AF delivery in accordance with the ESMF that was prepared after effectiveness in accordance with the ESCP requirements, and which will be updated to reflect the requirements for effective vaccine procurement and deployment. Moldova’s capacity to manage risks associated with COVID-19 is a major concern. There are gaps in the knowledge of lab personnel on biosafety risk management during COVID-19 diagnostic testing. The country also has had minimal experience in implementing public health measures necessary to control infection spread for contagions like COVID- 19, including enforcing quarantines, and social distancing. The Project has therefore provided funding to address these shortcomings through investments in equipment, supplies, training, and communication activities in line with evolving guidance from WHO on control of the COVID-19 pandemic. For instance, under Subcomponent 1.1 – Case confirmation – the Project has financed personal protective equipment, specimen transport kits, and light vehicles to support bio-safety risk management in laboratories. Under Subcomponent 1.3 – communication preparedness – the Project has supported a national communication and outreach strategy to address social and behavioral change, including the adoption of public health measures—quarantine, social distancing, wearing of face masks, and personal hygiene. In addition to the Project’s support for clinical waste management, other donors and CSOs have provided support to Moldova to strengthen its national capacity for medical waste management. Most recently, through an agreement Feb 16, 2021 Page 5 of 17 The World Bank Moldova Emergency COVID-19 Response Project - Additional Financing (P175816) with the European Bank for Reconstruction and Development (EBRD), Moldova has procured equipment to support the handling of medical waste during the COVID-19 pandemic in 12 of the 32 districts in the country. The Project will continue to invest in strengthening the capacity of the country to manage environmental and social risks and enforce public health measures. Under the new Subcomponent 1.5 – Vaccine procurement and deployment – the Project will support human resource training that will include appropriate handling of medical waste arising from the national COVID-19 vaccination campaign. Training commenced in January 2021 for over 600 staff in the health sector, and is organized by the MoHLSP, National Agency of Public Health, and the State Medical University, with support from UNICEF and WHO. Furthermore, the Subcomponent will support an expanded communications campaign to increase vaccination uptake. In tandem with the national COVID-19 vaccination program, a multifaceted communications campaign has been developed as part of a broader social engagement and mobilization strategy to address vaccine hesitancy, with tailored content and channels to target priority groups. The social engagement strategy to reduce vaccine hesitancy includes active disinformation management through social listening, review, and follow-up with exposed groups. The communication campaign will be implemented in all stages of the national vaccination rollout, and will leverage mass media, social media, and healthcare workers. II. SUMMARY OF ENVIRONMENTAL AND SOCIAL (ES) RISKS AND IMPACTS A. Environmental and Social Risk Classification (ESRC) Substantial Public Disclosure Environmental Risk Rating Substantial This AF has the same Project Development Objective (PDO) and institutional arrangements as the parent project. A new Subcomponent 1.5 has been added to support COVID-19 vaccine procurement and deployment. While the environmental risks for AF remain “substantial,” the nature of these risks is different given the new vaccination- related activities. The COVID-19 vaccination rollout also poses a lot of uncertainties that may need ad hoc decisions and adjustments. Although the main long-term impacts are likely to be positive, there are a number of short-term risks that need to be considered. The main environmental risks identified at this stage are: (i) the Occupational Health and Safety issues related to testing and handling of supplies during vaccination; (ii) the logistical challenges in transporting vaccines across the country in a timely and safe manner, adhering to the recommended temperature and transportation requirements; (iii) production and management of medical healthcare waste; (iv) community health and safety issues related to handling, transportation, and disposal of hazardous and infectious healthcare waste associated with vaccination, including sharps and used vaccine vials; and (v) minor environmental impacts—noise and dust emissions—from minor construction works in vaccine storage facilities. To mitigate these risks, in September 2020 the MoHLSP prepared an ESMF, which contains provisions for storing, transporting, and disposing of contaminated medical waste. The document also outlines guidance in line with international good practice and WHO standards on COVID-19 response on limiting viral contagion in healthcare facilities. This will be updated by project effectiveness to account for the AF funded activities, with environmental risks largely focused around vaccine procurement, distribution and administration and minor works related to vaccine Feb 16, 2021 Page 6 of 17 The World Bank Moldova Emergency COVID-19 Response Project - Additional Financing (P175816) storage facilities. While the draft ESMF will require revisions, the current draft includes an Infection Prevention and Control and Waste Management Plan, which will also be revised to reflect evolving procedures for management of waste associated with vaccination. In addition to the ESMF, the MoHLSP will implement the activities listed in the ESCP, which will be updated by AF effectiveness. The Project and AF will continue to support the MoHLSP in coordination with UNICEF, WHO, and other development partners in overcoming logistical constraints in the timely provision of technical expertise, supplies, equipment, and systems across the country for the COVID-19 response. Under the national COVID-19 vaccination deployment plan, UNICEF will support the assessment of the Borrower’s capacity to establish and implement a monitoring system of vaccine cold chain temperatures that should cover the whole chain including transport, storage and handling of vaccines. UNICEF will also support the development of standard operating procedures for collection and disposal of medical waste, and a demand generation plan to increase confidence in and acceptance of a COVID- 19 vaccine in the population. The WHO will provide technical leadership for vaccine deployment, including coordination of the NTWG, development of national vaccine deployment plan, and the regulatory framework for approval and import of COVID-19 vaccines. The parent project will continue to support minor rehabilitation works (repairs) of ICUs in selected hospitals. The location of ICUs will be selected based on existing services and human resources capacities and expanding geographical access to health care services in order to ensure equitable access to highly specialist care across the country. All works will be interior and implemented within the existing footprint of the target facilities; thus, the environmental impacts are expected to be low in magnitude, reversible, predictable and temporary. Public Disclosure Social Risk Rating Substantial The AF has the same PDO and institutional arrangements as the parent project. However, with the inclusion of the new subcomponent to support COVID-19 vaccination, the social risk is anticipated to be “Substantial” in Moldova, because according to a recent public release, Moldova is among the 67 countries which will be able to vaccinate only one in ten people against COVID-19 in 2021, unless urgent action is taken by the government and the pharmaceutical industry to ensure that enough doses are produced or made available. Also, it is considered that there is a broader social risk of inequity in access to vaccines, due to political pressures to provide vaccines to groups that are not prioritized based on need or vulnerability, bypassing the the elderly and medically vulnerable patients. Further, there may be traffic and road safety risks to community health and safety that arise during nationwide transportation of vaccines for deployment, including of injuries. This risk needs to be mitigated through several measures, including a communication and outreach campaign to ensure vaccine delivery targets the most vulnerable populations in accordance with criteria specified in this AF. As regards gender, the WHO notes that the risk of severe disease and death is higher in males than in females. However, in older age groups, this difference in risk is diminished when comorbidities and other factors are taken into account. In many contexts, women are disproportionately represented in high-risk occupation groups and they often have direct responsibility for caring for elders. At the same time, males are more likely to have multiple comorbidities or noncommmunicable diseases which increase the risk of severe COVID-19 disease. In some contexts, women are disadvantaged in terms of access to health care, political and social status, and decision-making authority due to social structural features in some communities. As both genders experience increased risk of disease or death through different pathways, the national COVID-19 vaccine deployment plan does not use gender to identify prioritized vaccine use cases. Feb 16, 2021 Page 7 of 17 The World Bank Moldova Emergency COVID-19 Response Project - Additional Financing (P175816) The World Bank will support the GoM to ensure transparent communication of the criteria for the selection of priority groups for access to the vaccines. The Project and AF will also have to ensure that the medical isolation of individuals does not increase their vulnerability—for example, to gender-based violence (GBV). Handling of quarantine interventions – dignified treatment of patients, attention to specific, culturally determined concerns of vulnerable groups, prevention of sexual exploitation and abuse and sexual harassment(SEA/SH) and meeting minimum accommodation and servicing requirements – will also require close attention. Social risks include social tensions that could be exacerbated by the Project and community health and safety-related outcomes, especially related to the spread of disease and waste management., Additionally, due to variance in communities’ or individual’s ability to pay, the risk of social exclusion is widespread in Moldova. The Stakeholder Engagement Plan (SEP) has been updated for this AF to engage citizens during vaccine rollout and through the Project, and for public information disclosure. The MoHLSP will make revisions to the SEP during implementation, as needed, to account for evolving information on the environmental and social risks of project activities and new modalities for a comprehensive community engagement and participation plan that will address improved hygiene, reduction in vaccine hesitancy, increased vaccine acceptance, enhancing physical distancing, and procedures describing access and eligibility for social protection activities of the project. B. Environment and Social Standards (ESSs) that Apply to the Activities Being Considered B.1. General Assessment Public Disclosure ESS1 Assessment and Management of Environmental and Social Risks and Impacts Overview of the relevance of the Standard for the Project: The parent project became effective on May 28, 2020. Critical procurement activities have been carried out in the first eight months of implementation, including 35 contracts for equipment, supplies and PPE signed and delivered under Subcomponents 1.1 and 1.2. Social assistance activities under the project supported by performance-based conditions have enabled transfers to over 54,000 poor households. The Project has developed a communication campaign focused on minimizing the spread of the virus. The campaign included video clips aired on national television; audio messages on safety measures broadcast in malls, shops, marketplaces, and on public transportation; and adverts placed on Facebook and LED billboards. Under the AF, the project scope has expanded to include vaccine procurement and deployment while the geographical coverage remains the same. The additional environmental risks may arise from activities supported under this second AF were presented in the Section A. Social risks on equal distribution of benefits to poor and vulnerable groups are presented in Section A above. The AF will have, akin to the Project, positive environmental and social impacts as it should improve COVID-19 surveillance, monitoring and containment, facilitate widespread rollout of the vaccine, and provide targeted support for vulnerable households. The measures to address social and environmental risks in the parent project remain relevant, including infection prevention and control improvements in health facilities, such as assessment and mitigation measures for medical waste risk management that will be expanded as inoculation sites expand. These risks are covered by ESS 1, ESS 2, ESS 3, ESS 4, and ESS 10. To mitigate these risks, under the parent project, the MoHLSP, with support from the PIU, prepared two major instruments: (i) an ESMF that includes templates for site-specific ESMP and an ICWMP template, that require that Feb 16, 2021 Page 8 of 17 The World Bank Moldova Emergency COVID-19 Response Project - Additional Financing (P175816) facilities to be supported by the Project will apply international best practices in COVID-19 diagnostic testing and other COVID-19 response activities (these activities may not be undertaken at the laboratories unless the appropriate capacity and infrastructure is in place); and (ii) a Stakeholder Engagement Plan (SEP) for effective outreach and citizen participation. This ESMF will be reviewed and updated by AF effectiveness to ensure reflect the additionalities brought in through this AF, mainly related to the monitoring and response systems in place for adverse events following immunization (AEFI), the priority groups for vaccination, the communication campaign for fair and inclusive access to vaccines, the planning of vaccine cold chain monitoring. These additions will be in line with international good practice, the WHO standards on limiting viral contagion viral contagion in health care facilities, and the WHO Global Manual on Surveillance of Adverse Events and on the Temperature Monitoring in the Vaccine Supply Chain. In Moldova, there is significant capacity to monitor, report, and respond to adverse events following AEFIs, including regulations, clear institutional responsibilities, and capacity at the facility and regional level to implement said provisions. Surveillance of AEFIs is performed based on the AEFI Surveillance Guide and the MoHLSP Order no. 1019 from November 5, 2020 "On the Operation of the System for Assessing Causality and Classification of Adverse Events Following Immunization (AEFI)". This Order approves the list of adverse events to be registered, investigated and reported, as well as forms for reporting and epidemiological investigation of AEFIs. The order also approves the composition and procedures for the commission for evaluating the reported AEFIs. The NAPH coordinates the epidemiological investigation of AEFI cases, monitors AEFI nationally, and maintains the secretariat for the evaluation of AEFIs. The territorial subdivisions of NAPH are responsible for the registration of cases, epidemiological investigation of AEFI at territorial level, and reporting the AEFI cases to NAPH central level. AMMD maintains a database of AEFIs and reports incidents to the WHO International Pharmacovigilance Center. Public Disclosure The National COVID-19 vaccine deployment plan requires every vaccination team to practice a segregated waste collection procedure at the source of vaccination in accordance with Government Decision 696/2018 related to management of medical waste. The ESMF includes an ICWMP template for COVID-19 identification, testing, and treatment. The development of the project ICWMP, prior to AF project effectiveness, will identify if the existing private companies cover the needs of the whole country, or if there is a need to address specific regions to support to better manage COVID-19 pandemic. The ICWMP template will be adapted to incorporate considerations for management of medical waste such as used vials and sharps associated with vaccination. Project implementation will not imply transboundary movement of specimens, samples, or any hazardous materials. Only in-country transportation is expected. Site-specific ICWMPs will be developed within 45 days of their being identified. In a November 2020 survey on behavioral insights on COVID-19, 31 percent of the population would accept a safe and effective COVID-19 vaccine. The WHO’s “A practitioner's guide to the principles of COVID-19 vaccine communications” informed the design of the social engagement strategy to improve vaccine uptake. The communication campaign will ensure vaccine delivery targets vulnerable populations, in accordance with criteria specified in this AF. The multifaceted communications campaign has tailored content and channels, to target priority groups. The strategy to reduce vaccine hesitancy includes active disinformation management through social listening, review, and follow-up with exposed groups. The communication campaign will be implemented in all stages of the national vaccination rollout, and will leverage mass media, social media, and healthcare workers. The World Bank will continue to provide technical and implementation support to mitigate the risk of low uptake of the vaccines. The process of prioritization of groups for vaccination was led by the Moldovan authorities in consultation with key stakeholders including health experts, representatives of National Agency for Public Health, National Social Assistance Agency, line ministries, development agencies, and CSOs. Priority groups for COVID-19 vaccination have Feb 16, 2021 Page 9 of 17 The World Bank Moldova Emergency COVID-19 Response Project - Additional Financing (P175816) been defined in accordance with WHO and the Strategic Advisory Group of Experts on Immunization (SAGE). The prioritization approach was endorsed by the NITAG members on December 9, 2020. The SAGE framework advocates for the prioritization of groups for vaccination, based on the principles of human wellbeing, equal respect, equity, reciprocity, and legitimacy. The GoM has prioritized health and social workers, the elderly, people living with comorbidities, and teachers for preferential access to COVID-19 vaccines. These groups are identified in the January 2020 National COVID-19 Vaccine Deployment Plan. The rollout of vaccines to 70 percent of the population will occur in four stages. The first stage will cover initial 20 percent by mid-2021. The second stage will cover an additional 10 percent by the end of 2021, the third and fourth stages will cover a further 40 percent by the end of 2022. In the first stage, the COVAX Facility will provide fully subsidized vaccine doses for 20 percent of the population. World Bank financing will support vaccine procurement in the second to fourth stages. Another potential social risk is the increased incidence of reprisals, against healthcare workers and researchers. However, this risk will be mitigated through robust stakeholder identification and consultation processes throughout the project. The SEP is a key instrument for outreach to the community at large on issues related to social distancing, higher risk demographics, self-quarantine, and medical quarantine. It is critical that these messages be widely disseminated, repeated often, and clearly understood. Each ICU, laboratory, and quarantine facility will apply the ICWMP following the requirements of the ESMF and relevant guidelines from Good International Industry Practice (GIIP), WHO, etc. The ESMF covers environmental and social infections control measures and procedures for the safe handling, storage, and processing of COVID-19 materials including the techniques for preventing and controlling environmental and Public Disclosure social impacts during the operation of project-supported facilities. It outlines the implementation arrangement to be put in place by the MoHLSP for environmental and social risk management, training programs focused on biosafety, operation of quarantine and isolation centers and screening posts, as well as compliance reporting requirements on waste management. The SEP was updated for this AF and will be regularly updated during project implementation, to reflect additional measures for ensuring the involvement of most vulnerable groups, and incorporating their feedback in vaccine deployment. The environment and social risk management actions are clearly identified in the updated ESCP which will be implemented by the MoHLSP. The Borrower will supplement the PIU's capacity to address potential areas of weaknesses by hiring additional consultants for waste management and public communication, to support the environmental and social specialists. ESS10 Stakeholder Engagement and Information Disclosure Stakeholder and community engagement, and effective communication are essential to the success of COVID-19 vaccine programs. The prioritization of groups for vaccine access has been informed by a transparent process, involving shared values, guidance from WHO, and the appropriate representation and input by affected parties. Further prioritization, as the global supply constraints for COVID-19 vaccines are relaxed, will be conducted in a similar manner. Feb 16, 2021 Page 10 of 17 The World Bank Moldova Emergency COVID-19 Response Project - Additional Financing (P175816) The consultative approach of prioritization ensures that affected communities gain better understanding of the project benefits and activities. Stakeholder engagement will continue through all stages of vaccine rollout. The timing and methods of engagement with identified stakeholders has been outlined in the SEP prepared for the Project by the Borrower. The SEP prepared for the parent Project has been updated to reflect the scale-up of activities under AF to include the following : (i) updated stakeholder identification and analysis; (ii) planning engagement modalities, effective communication tools for consultations and disclosure; (iii) enabling platforms for influencing decisions; (iv) defining roles and responsibilities of different actors in implementing the Plan; and (iv) an updated grievance redress mechanism (GRM). The parent project has established a GRM to receive and address concerns emerging during implementation in a transparent and accountable manner. Citizens can also submit grievances using the “green-line,” email address, and by direct comments on the dedicated Facebook page of the MoHLSP. The parent project and first AF have recorded no grievances, as in general, in Moldova, the public response to Government programs tends to be slow. Once the public outreach and communication campaign is launched, people may have better knowledge on the project activities to lodge any grievances. The GRM will respond to complaints throughout the project lifecycle and has been devised to promptly respond to any project grievances. The GRM is continuously being analyzed and strengthened, enabling stakeholders to air their concerns, comments, and suggestions, and allows anonymous grievances to be raised and addressed, an appeal process for unsatisfactory complainants, and provides accessible grievance uptake channels—online and offline, including telephone, text message, email, and grievance boxes. In addition, national hotlines are accessible countrywide, free of charge, by the public. Complaints are also received by the anti-corruption center and forwarded to the MoHLSP for review. The MoHLSP keeps records in a register and maintains a database Public Disclosure on the complaints and resolved cases. The SEP will be updated on a quarterly basis to reflect additional measures for ensuring the involvement of disadvantaged groups and incorporating their feedback for equitable vaccine deployment. The project GRM will also be enhanced by placing additional channel to register and respond to complaints and feedback linked with deployment of vaccination, as the primary objective of the AF is to enable equitable access to COVID vaccines. The GRM will also be sensitized to receive grievances on AEFIs and related issues. The national vaccination program will be based on strategic approaches to promote public trust and acceptance of the COVID-19 vaccine. Approaches will deploy practical ways to improve the public’s perception and understanding of vaccine development and prioritization processes and cover: (i) culturally and linguistically accessible communications made freely available regarding COVID-19 vaccination; (ii) recruitment of community opinion leaders to improve awareness and understanding of such communications; and (iii) inclusion of diverse and affected stakeholder opinions in decision-making. Efforts towards community engagement and effective communication are additionally important in subpopulations which may be unfamiliar with or distrustful of health-care systems. During implementation, the list of stakeholders may be expanded to include additional interested parties. However, individuals and groups likely to be affected – direct beneficiaries – have been identified. Risk hotspots on the international borders, as migrant workers move across borders with Romania and Ukraine, and in-country have been delineated. Mapping of other interested parties such as government agencies and authorities, nongovernmental organizations (NGOs), civil society organizations (CSOs), and other international agencies have also been completed. Key stakeholders will include national health authorities and government bodies, NITAG, UN bodies and other international organizations, civic associations working for elderly populations, private sector organizations with a role Feb 16, 2021 Page 11 of 17 The World Bank Moldova Emergency COVID-19 Response Project - Additional Financing (P175816) in immunization, educational institutions at all levels, NGOs, religious organizations and community groups—for example, representing key population groups such as culturally and linguistically diverse communities such as the Roma, and people committed to vaccine advocacy—science journalists, the media, and national science media centers. It must be noted that NITAG consists of representatives of national bodies involved in immunization and doctors of various specialties, including infectious diseases, pediatrics, immunology, and public health. Based on WHO guidance, the overall purpose of the stakeholder engagement and consultation process is to build trust in the prevention and response of misinformation that may interfere with decision-making in the population for Coronavirus disease (COVID-19) and to adhere to public health advice. This will include scientifically sound information on relevant vaccines. This work would be based on WHO guidance (WHO Guidance - Risk Communication and Community Engagement) and would seek to provide proper awareness raising and timely information dissemination to (i) avoid conflicts resulting from false rumors; (ii) ensure equitable access to services for all who need it; and (iii) address issues resulting from people being kept in quarantine. B.2. Specific Risks and Impacts A brief description of the potential environmental and social risks and impacts relevant to the Project. ESS2 Labor and Working Conditions The AF, like the parent project, will be carried out in accordance with the applicable requirements of ESS2, in a manner acceptable to the World Bank. This includes inter alia, implementing adequate occupational health and safety measures for emergency preparedness and response measures, setting out grievance arrangements for project Public Disclosure workers, and incorporating labor requirements into the environmental, social, health and safety (ESHS) specifications of the procurement documents and contracts with contractors and supervising firms. To accommodate the additional activities under the AF, procedures are being implemented under the Project to prevent and control the spread of infection among vaccinators. These include separate COVID-19 vaccination days in health facilities versus other care, improved ventilation for waiting areas, temperature checks, protective masks, personal hygiene, and observing the one-meter distancing requirement. Furthermore, the National Association of Public Health and the Nicolae Testemitanu Medical University are organizing trainings, with support from WHO and UNICEF, on occupational health and safety measures, including infection control. The Project and the AF are expected to encompass direct workers and contracted workers. Direct workers could be either government civil servants or those deployed as technical consultants by the Project. The ESMF includes Labor Management Procedures (LMP) and sections on Environment Health and Safety (EHS), including, inter alia, emergency preparedness and response measures, setting out grievance arrangements for Project workers (including workman compensation in case of COVID-19 infection), and incorporating labor requirements into the ESHS specifications of the procurement documents. Also, the risks associated with distribution and transport of vaccines including SEA/SH risks as well as traffic/road safety risks associated with safety of drivers transporting vaccines around the country will be assessed and appropriate mitigation actions will be outlined in the updated ESMF. The LMP will be revised and developed as a stand-alone document, consulted upon, and disclosed no later than 30 days after the Effective Date of the AF. Feb 16, 2021 Page 12 of 17 The World Bank Moldova Emergency COVID-19 Response Project - Additional Financing (P175816) Healthcare associated infections due to inadequate adherence to occupational health and safety standards can lead to illness and death among health and laboratory workers. The laboratories to be supported by the project will process COVID-19 tests and will therefore have the potential to cause serious illness or potentially lethal harm to the laboratory staff and to the community. Hence, effective administrative and containment controls have been put in place to minimize these risks. Environmentally and socially sound health facilities management requires adequate provisions for minimization of occupational health and safety risks, proper management of hazardous waste and sharps, use of appropriate disinfectants, proper quarantine procedure for COVID-19, appropriate chemical and infectious substance handling and transportation procedures, etc. These measures are covered in the ICWMP template and other relevant sections in the draft ESMF and are based on the national healthcare delivery standards and norms set by the MoH in addition to WHO guidance. The necessary protocols for treating patients, handling medical waste, and disinfecting, regular testing of healthcare workers, requirements for proper disposal of sharps, along with the environmental health and safety guidelines for staff and necessary PPE, are included in ICWMPs adopted and implemented by facilities and and laboratories participating in the project. In line with ESS2 and Moldova laws, the use of forced labor, child, or conscripted labor is prohibited in the project, including for construction and operation of health care facilities. The LMP incorporates the portion of the national law provisions which regulate labor rights, working hours, sick leave, adjusting work practices, restrictive measures and addressing grievances for workers. The site-specific ESMPs will include provisions in line with national regulations relating to the protection of workers and communities from exposure to asbestos. Exposure to asbestos during minor renovations of ICU roofing and other Public Disclosure sources will be reduced to a minimum, including by minimizing the number of persons exposed, prioritizing dust-free work processes, cleaning buildings and ensuring that materials are properly stored, transported and labelled. If it is foreseeable that exposure cannot be limited, following consultation with workers, the employer shall ensure protection, including by providing proper personal protective equipment, training workers, putting up warning signs and preventing the spread of asbestos dust. Exposure to communities will be limited by evacuating residents at risk of exposure prior to undertaking said works. ESS3 Resource Efficiency and Pollution Prevention and Management Medical wastes and chemical wastes will be generated by the laboratories, quarantine, and screening posts to be supported withdrugs, supplies and medical equipment, and from the vaccination processes in facilities and mobile units, with potential impacts on the environment and human health. Wastes that may be generated from medical facilities and laboratories could include liquid contaminated waste, chemicals, and sharps used in diagnosis and treatment. Vaccination will involve the generation of additional sharps, used vaccination vials, and other disposable supplies. Medical wastes and general waste from the laboratories, health centers, and quarantine and isolation centers have a high potential for carrying micro-organisms that can infect the community at large if they are is not properly disposed of. Infectious microorganisms could be introduced into the environment if not well contained within the laboratory, or due to accidents and emergencies such as a fire response or natural phenomenon, for example, seismic. Laboratories, quarantine and isolation centers, and screening posts, will thereby have to follow procedures detailed in the ESMF. The MoHLSP with support from the environmental specialist in the PIU will develop, by AF project Feb 16, 2021 Page 13 of 17 The World Bank Moldova Emergency COVID-19 Response Project - Additional Financing (P175816) effectiveness, an ICWMP that specifies the necessary protocols for treating patients and handling medical waste, disinfectant protocols, regular testing of healthcare workers, requirements for proper disposal of sharps, along with the environmental health and safety guidelines for staff and necessary PPE, that will be adopted and carried out by medical facilities and laboratories participating in the project. Site-specific ICWMPs will be developed within 45 days of their being identified for project investments. Based on the Project’s ICWMP, to be developed and adopted by AF project effectiveness, each beneficiary medical facility/laboratory, following the requirements of the ESMF, WHO COVID-19 guidance documents, and other international best practices, will prepare and follow a site-specific ICWMP to prevent or minimize such adverse impacts. The ICWMP will mandate that any waste associated with COVID-19 testing or treatment will be incinerated using appropriate equipment on site whenever appropriate location for disposal of post-incineration residues is possible. It will also contain strict protocols for disinfecting and packing such waste for transportation to the nearest medical waste incinerator if on site destruction is not possible. Presently, in Moldova the treatment of infectious waste by incineration is carried out in facilities located on the territory of medical institutions in the districts of Calarasi, Ceadir-Lunga (of TAU Gagauzia), Cimișlia, Comrat, Drochia, Glodeni, Nisporeni, ȘtefanVodă, and Telenesti— nine out of 33 territorial-administrative units of the country. The ESMF includes guidance related to transportation and management of samples and medical goods or expired chemical products, as well as small scale rehabilitation activities. According to the Sanitary Regulation on the management of waste resulting from medical activity, approved in Moldova, each hospital or medical care unit is obliged to have a special space for temporary storage of medical waste. The packaging of waste resulting from Public Disclosure medical activity, including hazardous waste, is carried out to allow its disposal with minimal risk to the environment and public health. The temporary storage points for hazardous medical waste is marked with appropriate symbols, warning of the nature of the hazard of the chemicals. The activity of collecting, transporting, and autoclaving medical waste is organized by specialized companies certified by the Ministry of Agriculture, Regional Development and Environment. The site-specific ESMPs, to be prepared for rehabilitation of the ICUs in selected hospitals will include procedures for handling construction waste, including hazardous waste such as asbestos that could be associated with the renovation of the ICU facilities. The site-specific ESMPs will include provisions on the safe handling of asbestos wastes, including labeling, storage, transport, and final disposal in line with national regulations. Handwashing facilities, restrooms, or other basic health and hygiene conditions will be improved through safe wastewater management—mini septic tanks, etc. Resources such as water and air used in health care and quarantine facilities and laboratories will follow standards and measures in line with the State Sanitary Hygienic Service of MoHLSP and WHO environmental infection control guidelines for medical facilities. ESS4 Community Health and Safety Community Health and Safety will include comprehensive communication about COVID-19 vaccine access and safety, including AEFIs, and play a key role in maintaining the public’s confidence in vaccination. Under the Project, procedures, protocols, and communication measures will be developed in line with the national social engagement and mobilization strategy to ensure voluntary consent for vaccination. The National Agency for Public Health plans to conduct vaccination in 80 hospitals – for health workers – and 1,400 family doctor centers – for social workers, the Feb 16, 2021 Page 14 of 17 The World Bank Moldova Emergency COVID-19 Response Project - Additional Financing (P175816) elderly, individuals with comorbidities, teachers, defense and security staff, and other groups. Where the facility deems necessary to ensure better access, mobile teams will be deployed to undertake vaccination in the community. Vaccination will be done by medical staff only, in accordance with approved procedures and protocols. There has been no need for security personnel in project implementation and the engagement of security or military personnel in the implementation of project activities is not anticipated. Planning for communication about COVID-19 vaccine safety will include (i) involving a communications team in vaccine safety work and develop strategic messaging; (ii) establishing strategic partnerships; (iii) setting up communication pathways with the public; and (iv) identifying potential threats to confidence in vaccine safety. The communication strategy on vaccination under the project will include messages on vaccination safety, AEFIs, and will carefully consider the communication environment, cultural and religious influences and expectations created by political leaders. The strategy will align with the developed national strategy for social engagement and mobilization for the national COVID-19 vaccine deployment campaign. Frontline healthcare workers will be the focus of early vaccination efforts and are considered important influencers. The communication approach on vaccination will reflect the fact that the population may have diverse views on vaccination, ranging from those advocating for or demanding COVID-19 vaccines to those who reject them and a small group of anti-vaccine activists who will oppose COVID-19 vaccines. Studies describe individual factors associated with lower vaccination intentions including lower education and health literacy levels, lower income and young or old age. People are likely to shift their intentions over time as new information about COVID-19 vaccines becomes available. Interactions between groups such as activists and hesitant Public Disclosure people can also trigger changes in views on vaccination. The Project will support the MoHLSP to adopt measures to reduce stigma around the COVID-19 vaccine. Overall, the goal of vaccine safety communication will be to empower people to make evidence-informed decisions about COVID-19 vaccination. Any communication approach should encourage trust in health authorities and those delivering the vaccine, facilitate access to timely, accurate and credible information about COVID-19 vaccination safety via trusted channels, and provide people with a means of asking questions and having their concerns addressed. For the broader COVID-19 response, the operation of quarantine and isolation centers will continue to be implemented in a way that staff, patients, and the wider public follow and are treated in line with international best practice as outlined in WHO guidance for COVID-19 response as above under ESS1 and ESS2. The SEP will continue to ensure widespread engagement with communities in order to disseminate information related to community health and safety, particularly around social distancing, high risk demographics, self-quarantine, and mandatory quarantine. The AF, similarly as the Project, will continue to mitigate the risk of SEA/SH by applying the WHO Code of Ethics and Professional Conduct for all workers in the quarantine facilities as well as the provision of gender-sensitive infrastructure, such as segregated toilets and enough light in quarantine and isolation centers. The existing GRM will be strengthened to receive and respond grievances related to GBV/SEA/SH and the localized GRM (at health care facility level) will be established. The AF and the Project will also ensure via the above-noted provisions, including stakeholder engagement, that quarantine and isolation centers and screening posts are operated effectively throughout the country, particularly in remote and border areas, without aggravating potential conflicts between different groups. At least 45 days prior to the engagement of any security personnel in the activities associated with the project, the project will prepare a Feb 16, 2021 Page 15 of 17 The World Bank Moldova Emergency COVID-19 Response Project - Additional Financing (P175816) stand-alone security management plan including applicable laws and a Code of Conduct, that must be adopted with respect to hiring, rules of conduct, training, equipping, and monitoring of such personnel. The risks and impacts associated with the engagement of the security or military personnel will be assessed by the Effective Date of the AF. The GRM will be strengthened to accommodate any grievances related to activities of security personal and their behaviors during vaccination distribution. Finally, the traffic and road safety risks to the community arising during vaccine transportation will be assessed and mitigation actions outlined in the updated ESMF. ESS5 Land Acquisition, Restrictions on Land Use and Involuntary Resettlement This ESS is not relevant. There will be no new construction or reconstruction activities, except minor refurbishing activities. No physical or economic displacement is expected. There will be no restrictions on land use/land access. ESS6 Biodiversity Conservation and Sustainable Management of Living Natural Resources This ESS is not relevant. All works will be conducted within the existing footprint of selected facilities and the proposed project interventions will have no impacts to the biodiversity and habitats. ESS7 Indigenous Peoples/Sub-Saharan African Historically Underserved Traditional Local Communities This ESS is not relevant to the proposed project. There are no social and cultural groups as defined by ESS7 in Moldova. Public Disclosure ESS8 Cultural Heritage This ESS is not relevant. ESS9 Financial Intermediaries This ESS is not relevant. This project will not involve any FIs C. Legal Operational Policies that Apply OP 7.50 Projects on International Waterways No OP 7.60 Projects in Disputed Areas No B.3. Reliance on Borrower’s policy, legal and institutional framework, relevant to the Project risks and impacts Is this project being prepared for use of Borrower Framework? No Feb 16, 2021 Page 16 of 17 The World Bank Moldova Emergency COVID-19 Response Project - Additional Financing (P175816) Areas where “Use of Borrower Framework” is being considered: Not Applicable IV. CONTACT POINTS World Bank Contact: Adanna Deborah Ugochi Chukwuma Title: Health Specialist Telephone No: 5220+33931 Email: achukwuma@worldbank.org Contact: Volkan Cetinkaya Title: Senior Economist Telephone No: +1-202-473-5084 Email: vcetinkaya@worldbank.org Borrower/Client/Recipient Borrower: Republic of Moldova Implementing Agency(ies) Implementing Agency: Ministry of Health, Labor and Social Protection Public Disclosure V. FOR MORE INFORMATION CONTACT The World Bank 1818 H Street, NW Washington, D.C. 20433 Telephone: (202) 473-1000 Web: http://www.worldbank.org/projects VI. APPROVAL Task Team Leader(s): Adanna Deborah Ugochi Chukwuma, Volkan Cetinkaya Practice Manager (ENR/Social) Varalakshmi Vemuru Cleared on 09-Feb-2021 at 15:34:12 GMT-05:00 Safeguards Advisor ESSA James Peter Moore (SAESSA) Concurred on 16-Feb-2021 at 09:22:36 GMT-05:00 Feb 16, 2021 Page 17 of 17