25681 THE WORLD BANK GROUP 4X~oShop The W'x1d iJk Report No AC080400 Integrated Safeguards Data Sheet (Initial) Date ISDS Prepared/Updated: 03/27/2003 Section I - Basic Information A. Basic Project Data Country: BRAZIL Project ID: P080400 Project: BR-AIDS & STD Control III Task Team Leader: Sandra Rosenhouse Authorized to Appraise Date: March 24, 2003 IBRD Amount ($m): 100.00 Bank Approval: May 29, 2003 iDA Amount ($m): Managing Unit: LCSHH Sector: Health (100%) Lending Instrument: Specific Investment Loan (SL) Theme: Fighting communicable diseases (P) Status: Lending I.A.2. Project Objectives: Following are the main objectives of this project: * Reduce the incidence of STDs, and HIV * Improve the quality of life for people living with HIV/AIDS (PLWHA) * Strengthen the sustainability of the national response These objectives would be reached by: (a) expanding the coverage and quality of interventions; (b) decentralizing the financing and management of program activities to states and municipalities in accordance with current national health policy, (c) strengthening program management by establishing an effective M&E capacity and instituting the use of management tools, including performance-based management, focusing on more cost-effective interventions and improving their targeting; (d) introducing technological innovation and upgrading existing technology in treatment and prevention; and (e) reducing discrimination and stigma associated with HIV/AIDS. I.A.3. Project Description: COMPONENT 1: Improving the Quality and Coverage of Prevention, Treatment and Care. (US$166 million). Component I has four subcomponents, of which the first three include financing for centrally financed initiatives. They are centrally funded as they include investments that are national or regional, i.e. involve more than one municipality or state, or are of a strategic nature, i.e. address a particular issue, the need to address emerging issues, or in cases where municipalities were unable to address the issue adequately. The last subcomponent includes municipal and state-managed initiatives funded through direct transfers from the federal level to the state or municipal levels. Subcomponent 1.1: Prevention of STDs and HIV. The activities to be financed under this subcomponent include promotion of behavior change to prevent STDs and HIV with a strong focus on high risk groups, mother to child transmission, condom promotion, risk reduction among IV drug users (needle exchange programs), expansion of voluntary counseling and testing services and IEC (information, education and communication). Subcomponent 1.2: Treatment and Care. This subcomponent would finance expanded diagnosis and treatment for STDs, treatment of opportunistic infections and HIV/AIDS (although ARV drugs are not supported by the 2 ISDS project, this subcomponent is financing activities to improve logistics, expand dispensing units, training staff to foster adherence, and increasing access to CD4 and viral load testing), home-based social/psychological care and palliative care. The laboratory network will be strengthened and some facilities will be upgraded. Subcomponent 1.3: Human Rights. The protection of human rights will encourage people to get tested and to seek treatment, and thus is an important component of both prevention and treatment. This component will finance workshops to sensitize PLWHA on their rights, training for lawyers and judges on universal access to ARV, activities to empower PLWHA to exercise their rights, and training for health professionals on ethics and human rights. Subcomponent 1.4: Municipal and State Initiatives in Prevention, Treatment and Care. This subcomponent includes similar activities to those funded under the rest of Component I except it includes only those activities that are to be managed by the state and municipal coordination units and financed through funds transferred directly from the federal government. A total of 41 1 municipalities and 27 states are eligible to receive fund-to-fund transfers from the federal government on the basis of agreed annual action and target plans (PAMs). States and municipalities with adequate PAMs will qualify to receive federal transfers. In cases where municipalities do not qualify, states will receive their funds and manage them for the municipality. Ten percent of funds transferred to the states are earmarked for NGO activities, for a total of US$2.8 million annually, or US$8.4 million for the duration of the project. An additional amount of US$12.0 million from the loan will finance NGO activities through this subcomponent, bringing the total going to NGOs to approximately US$7.0 million annually. COMPONENT 2: Scientific and Technological Development (US$ 9 million). This component will strengthen the capacity of research centers, laboratories and universities to engage in scientific and technological research and development (R&D), and will finance R&D studies and activities to improve the effectiveness of treatment and prevention of HIV/AIDS. The R&D activities are expected to be undertaken by public entities, several of which have international credibility. Partnerships with international agencies specializing in the issues addressed will be formed in order to ensure quality and effectiveness of the actions proposed. This does not differ substantially from what happens in the U.S. where NIH conducts or supports most basic research and some development. The project would not finance the actual production of medications nor medical supplies, but options for encouraging private sector participation in future production will be discussed during appraisal. The project could finance the development of a strategy for private sector involvement In addition, the type of partnerships with agencies specializing in R&D will be agreed upon and assurances that no patents will be broken will be obtained. Subcomponent 2.1: Strengthening capacity for scientific and technological research and development. This component will strengthen the capacity of research centers, laboratories and universities to engage in scientific and technological research and development (R&D) to improve effectiveness and increase access to treatment and prevention of HIV/AIDS. It would develop good clinical practices (GCP) in public clinical sites to provide clinical support for participation in phase 1, II and III clinical trials for the development of AIDS prevention vaccines and microbicides, bio-informatics support for clinical trials, and activities to prepare and promote civil society participation in clinical trials. It will also develop capacity for good manufacturing practices (GMP) centers of excellence, and for the establishment of methods and infrastructure to ensure quality control of medications and medical supplies produced. Subcomponent 2.2: Technological research and development. The second subcomponent will finance R&D in the following areas: development of combinations of two or three ARVs (not under patent protection) in a single presentation to increase adherence to treatment; studies on the molecular structure of pharmaceuticals with antiretroviral effects to identify possible effects in new synthetic molecules; testing the potential antiretroviral effects and anti-STD effects of potenlial candidates; a phase 1 trial to assess microbicide effects of an indigenous plant and pre-clinical evaluation of other products with potential microbicide effects; transfer of technology to develop reagents for confirmatory diagnostic tests for HIV while at the same time build local capacity; research to develop reagents for CD4 cell count and viral load tests to diagnose and monitor HIV infection; and studies to develop products that can be employed to test the effectiveness of vaccines, reagents and microbicides. 3 ISDS COMPONENT 3: Strengthening Program Management (US$ 25 million): This component aims to strengthen the overall management of the program, steering it towards results-based management practices. The project would support the establishment of an M&E unit at the national level, strengthening of capacity for monitoring at the state level, a series of evaluation studies incorporated in an M&E Operational Plan, a system to monitor compliance with PAMs agreed with municipalities and states to receive federal transfers, and activities to develop a culture of performance-based management. It would also support the development of software to improve logistics and management systems necessary for the improved operation of the project Subcomponent 3.1: PAM implementation and monitoring. This subcomponent would finance the preparation of municipalities and states for participation m the decentralized financing and management of services by providing training necessary to prepare PAMs, improve planning and management, and to set up and manage NGO competitive funds. To ensure improved sustainability of NGOs under decentralized financing, training in management, income generation and on the identification of alternative sources of financing will be provided. NGO forums will be established where non-existent, and strengthened elsewhere to strengthen their negotiation capacity vis-a-vis the states/municipal governments, providing them with political, institutional and financial sustainability. Activities for monitoring the meeting of agreed targets associated with the fund transfers to states and eligible municipalities would also be financed. Subcomponent 3.2: Monitoring and Evaluation. This subcomponent includes the establishment and operation of a Monitoring, Evaluation and Planning Unit at the federal level, and sentinel M&E units at the state level, with a minimum of one per region. A draft M&E Operational Plan prepared during project preparation will be finalized and will serve as a guide for the implementation of M&E activities A subset of states will be selected early on to function as sentinel M&E sites where different decentralized monitoring initiatives will be piloted to be disseminated to other states once the mechanisms are specified and tested. Relevant staff in states and large city municipalities will be trained on the use of information for decision-making. Some additional tools will be developed. The component will finance a series of evaluation and operational research studies to assess program effectiveness, many of which were identified during preparation. A detailed list will be included in Annex 2e on Monitoring and Evaluation. Activities designed to strengthen HIV/AIDS and STD surveillance at all three levels of government are included, with an emphasis on HIV and STD surveillance. Subcomponent 3.3: Strategic Planning and Performance Based Management. This subcomponent will promote a culture of use of information for management at the federal, state and municipal levels through training on the use of information for decision-making for NCU staff, managers at the national and state levels, and key project coordinators. Seminars, workshops and conferences for the exchange of information and methodologies will be held at the national level and sub-national level Participation in international fora to exchange ideas and information, and to provide guidance in such important initiatives as the Global Fund to Fight AIDS, TB and Malaria will also be financed. This component will also finance the supervision of project activities. Subcomponent 3.4: Project Management. The proposed project will finance a small coordination unit for the project, including PCU staff, technical assistance to ensure adequate implementation and supervision of the project, administrative expenditures for the PCU, office equipment, as well as operation and maintenance of office equipment as needed. It may include travel and subsistence expenses for PCU staff. I.A.4. Project Location: (Geographic location, information about the key environmental and social characteristics of the area and population likely to be affected, and proximity to any protected areas, or sites or critical natural habitats, or any other culturally or socially sensitive areas.) Project activities will take place throughout Brazil, primarily in urban centers where the epidemic has been centered since its inception. While all states will be receiving funds for prevention and treatment activities, the focus will be on the 41 1 municipalities which contain 98% of all AIDS cases, most of which are located in very urbanized areas. Given indigenous groups that have greater contact with urban centers are at a high risk of contracting AIDS, the project is working with FUNASA to provide adequate coverage to these groups. No civil works are envisioned other than minor rehabilitations to accommodate equipment or make minor improvements. All services are currently delivered in large urban areas. One of the objectives of the project is to 4 ISDS expand delivery to cover less urbanized cities. Given AIDS is primarily an urban phenomenon, no sites involving natural habitats or culturally sensitive areas will be affected. B. Clheck Environmental Classification: B (Partial Assessment) Commnents: This project is classified as Category B, considering the risk that may accompany the health care wastes emanating from the treatment of HIV/AIDS patients, and from clinical and laboratory studies conducted under Component 2 of the project. However, the environmental assessment indicated that the activities financed by the project are not expected to have a negative environmental impact Work on prevention, which generally takes place in the community, has if anything, positive environmental effects given its emphasis on health promotion. With regards to treatment and care, most services take place in outpatient facilities which generate 80% less waste than hospitals Both federal and state legislation clearly define procedures for the proper management and final disposal of health wastes. As to disposal of waste in health facilities and laboratories, the program has adequate procedures in place. No additional technology for managing health care wastes is needed to in the treatment of HIV/AIDS. Training for staff on handling of blood products and delivering health care to HlV/AIDS patients is a regular program activity. It can therefore be concluded that the environmental impacts arising from implementation of the AIDS III project are controllable with relatively simple measures. C. Safeguard Policies Triggered Policy Applicability Environmental Assessment (OP/BP/GP 4.0 1) 0 Yes 0 No 0 TBD Natural Habitats (OP/BP/GP 4.04) O Yes * No O TBD Forestry (OP/GP 4.36) O Yes * No O TBD Pest Management (OP 4.09) O Yes * No O TBD Cultural Property (OPN 11.03) O Yes * No O TBD Indigenous Peoples (OD 4.20) * Yes O No O TBD Involuntary Resettlement (OP/BP 4.12) 0 Yes * No 0 TBD Safety of Dams (OP/BP 4.37) O Yes * No 0 TBD Projects in International Waterways (OP/BP/GP 7.50) 0 Yes * No 0 TBD Projects in Disputed Areas (OP/BP/GP 7.60)* 0 Yes * No 0 TBD *By supporting the proposed project, the Bank does not intend to prejudice the final determination of the parties' claims on the disputed areas Section II - Key Safeguard Issues and Their Management D. Sumniary of Key Safeguard Issues. Please fill in all relevant questions. If information is not available, describe steps to be taken to obtain necessary data. TT.D. Ia. Describe any safeguard issues and impacts associated with the proposed project. Identify and describe any potential large scale, significant and/or irreversible impacts. Even though the Project does not have a direct impact on the environment, the provision of health services, and the implementation of laboratory and clinical studies, may generate medical wastes which might have direct envtronmental implications, since the final disposition of these wastes might have an impact on surrounding natural resources which, if are not handled properly can have negative effects. Although generally AIDS does not affect indigenous people more than the general population, it does significantly affect indigenous groups which have greater urban contact. In close partnership with FUNASA, the project has trained indigenous groups and NGOs working with indigenous groups to conduct prevention activities, training DSEI staff on the use of rapid HIV tests to provide access to testing, and training DSEI staff to provide HIV/AIDS treatment and care. FUNASA delivers the services, the National AIDS program trains staff, develops protocols, provides condoms and rapid tests, and ART. 5 ISDS lI.D.lb. Describe any potential cumulative impacts due to application of more than one safeguard policy or due to multiple project component. NA II.D.lc Describe any potential long term impacts due to anticipated future activities in the project area. The findings of the assessment carried out in October 2002 concluded that Brazilian federal and state environmental regulations and norms contain clear procedures and guidelines for environrmental assessment of health services, proper handling of medical wastes, proper final disposition of such wastes, and proper monitoring guidelines for reducing health risks. Federal, State and municipal roles are clearly stated as well. In addition, results from field visits to health centers in the State of Bahia and Goias indicate that local sanitary and environmental practices for proper handling and disposal of medical wastes are applied. Some concern remains regarding municipalities that will be participating in project activities for the first time as they have not received the necessary training to address health services wastes management related to HIV/AIDS. With regards to indigenous groups, there are no potentially large scale effects. Il.D.2. In light of 1, describe the proposed treatment of alternatives (if required) The limited negative environmental impacts that could occur can be significantly attenuated by following of guidelines already developed and providing regular training for all new participating entities. The latter is an integral part of the project. To ensure compliance, the program developed a long distance learning program (TELELAB) for laboratory workers and hemotherapy units to train them on health care waste management specific to AIDS/STD treatment and care which has been functioning for at least 6 years. In addition, the program provides an average of three one-week courses for each health care modality (SAE, conventional Hospitals, Day Hospitals and ADTs) on Care and Treatment Management, including a bio-safety module, and training for family to provide prLmary healthcare in STD/HIV/AIDS. In order to expand its service delivery network, the program has provided training, equipment and supplies to conventional hospitals so that they can become accredited to provide specialized services to patients with HIV/AIDS. It should be noted that REFORSUS, a project financed by IBRD and IDB, developed guidelines for the implementation of Health Service Waste Management Plans (HSWMP) which are being adopted by the SUS network Guidelines currently employed by the project will be reviewed to ensure they incorporate all procedures recommended by the REFORSUS guidelines, and will be included in the project's Operational Manual. All new participating facilities will have to submit an HSWMP that adequately addresses the handling of health care wastes emanating from project activities. With regards to indigenous people, see first point. Il.D.3. Describe arrangement for the borrower to address safeguard issues The findings of the EA were discussed with the project team during pre-appraisal Agreement was reached regarding proposed activities, most of which are already part of regular project activities (contained in the proposed Environmental Management Plan). Agreement was reached that the Project's Operations Manual and Project Implementation Plan would include the Environmental Management Plan. All actions are considered within the scope of the project's components and will be the responsibility of the NASCP. No additional staff nor funding are required for the monitoring and implementation of the plan. Supervision of municipal compliance with guidelines will be the responsibility of state level coordination units. Municipal coordination units will supervise compliance of facilities in their territory. Accreditation criteria of facilities already includes the adoption of bio-safety measures, and guidelines for handling health services waste related to HIV/AIDS. Indicators to measure performance under the fund-to-fund transfer sub-component are in the process of being defined. Agreement will be reached during appraisal to incorporate compliance with guidelines, and the provision of training. Indicators will be fine-tuned at the end of the first round of financing. With regards to indigenous people, the IPDP was developed with the borrower. As noted above, FUNASA is 6 ISDS responsible for providing health services to indigenous people. The AIDS program supports FUNASA by providing training, protocols, ARV drugs, condoms and rapid tests for service delivery mn indigenous areas. They also fund local NGOs, including indigenous groups, to provide prevention activities. Il.D.4. Identify the key stakeholders and describe the mechanisms for consultation and disclosure o01 safeguard policies, with an emphasis on potentially affected people. Environment: Ministry of Health staff at all levels, and NGOs providing home-based care and working with IDUs are the people at risk of any environmental effects. Training received to work with AIDS and HIV infected individuals includes information on proper health services waste management. Indigenous: Indigenous people form part of the staff of the Distritos Sanitarios Indigenas (DSEI), and form part of NGOs working in the area. Both staff from DSEIs and NGOs participate in the definition of the annual work plan for the AIDS Program and form part of the NGO forums of their state. NGO forums give a voice to NGOs in each state and serve to enhance the social accountability of the program. E. Safeguards Classif1cation. Category is determined by the highest impact in any policy. Or on basis of cumulative impacts from multiple safeguards. Whenever an individual safeguard policy is triggered the provisions of that policy apply. [ ] SI. - Significant, cumulative and/or irreversible impacts; or significant technical and institutional risks in management of one or more safeguard areas [X] S2. - One or more safeguard policies are triggered, but effects are limited in their impact and are technically and institutionally manageable [ ] S3. -No safeguard issues [ ] SF. - Financial intermediary projects, social development funds, community driven development or similar projects which require a safeguard framework or programmatic approach to address safeguard issues. F. Disclosure Requirements Environmental Assessment/Analysis/Management Plan: Expected Actual Date of receipt by the Bank 11/12/2002 11/12/2002 Date of "in-country" disclosure 10/28/2002 10/28/2002 Date of submission to InfoShop 3/28/2003 Date of distributing the Exec. Summary of the EA to the ED Not Applicable Not Applicable (For category A projects) Resettlement Action Plan/Framework: Expected Actual Date of receipt by the Bank Not Applicable Not Applicable Date of "in-country" disclosure Not Applicable Not Applicable Date of submission to InfoShop Not Applicable Not Applicable Indigenous Peoples Development Plan/Framework: Expected Actual Date of receipt by the Bank 3/18/2003 3/18/2003 Date of "in-country" disclosure 3/18/2003 3/18/2003 Date of submission to InfoShop 3/28/2003 Pest Management Plan: Expected Actual Date of receipt by the Bank Not Applicable Not Applicable Date of "in-country" disclosure Not Applicable Not Applicable Date of submission to InfoShop Not Applicable Not Applicable Dam Safety Management Plan: Expected Actual 7 ISDS Date of receipt by the Bank Not Applicable Not Applicable Date of "in-country" disclosure Not Applicable Not Applicable Date of submission to InfoShop Not Applicable Not Applicable If in-country disclosure of any of the above documents is not expected, please explain why. Signed and submitted by Name Date Task Team Leader: Sandra Rosenhouse 03/27/2003 Project Safeguards Specialists 1: Martin H. Ochoa/Person/World Bank 03/27/2003 Project Safeguards Specialists 2: Fernando Monteiro, Consultant PAHO 03/27/2003 Project Safeguards Specialists 3: Approved by: Name Date Regional Safeguards Coordinator: Juan D. Quintero 03/27/2003 Sector Manager/Director: Evangeline Javier 03/27/2003 For a list of World Bank news releases on projects and reports, click here .SEARCH S P irrE MAP ||HCAbSE E