Participação social na regulamentação da Anvisa: evidências híbridas, coloquiais e científicas para decisão democrática / Social participation in Anvisa's regulations: hybrid, colloquial, and scientific evidence for democratic decision-making

Resumo A consulta pública (CP) da Anvisa é o mecanismo de participação social mais usado na regulamentação, consolidada com base em movimentos antagônicos: democratização da tomada de decisão e contrarreforma do Estado. Diante do conceito de participação social como várias ações relacionadas à decisão pública com valorização da diversidade e como exercício da cidadania, o artigo discute a possibilidade de as CPs configurarem um processo de regulamentação democrático ao considerar saberes populares e evidências coloquiais, além de promover a criação de evidências híbridas em um modelo moderado de evidências. Apesar dos diferentes interesses, as CPs abrem oportunidades para deliberação democrática da sociedade na busca do entendimento, onde se espera que o Estado escolha a melhor decisão e a justifique. Dessa forma, delimita-se o papel das evidências a esclarecer questões complexas em um espaço em que o dissenso, visto como caminho para a democratização da sociedade, é importante para revelar as limitações das evidências científicas em um ambiente de assimetria de informações. Por fim, espera-se refutar a tecnocracia como instrumento de poder na regulação sanitária e assim alcançar o maior potencial democrático da regulamentação da Anvisa.

Abstract Anvisa's public consultation (PC) is the most widely used social participation mechanism in current health regulations, which was based on antagonistic movements: the democratization of decision-making and State counter-reformation. Starting from the concept of social participation, defined as various actions from society related to public decision-making, which values diversity and the exercise of citizenship, the present article discusses the possibility of PCs configuring a democratic regulation process by considering popular beliefs and colloquial evidence, and promoting the creation of hybrid evidence in an evidence-moderated model. Despite the different interests, the PCs open the door to opportunities for democratic deliberation by society in the search of understanding, where it is expected that the State will make the best decision and justify it. In this sense, the role of evidence in clarifying complex issues is defined as a space where dissent, believed to democratize society, is important in revealing the limits of scientific evidence in an environment of information asymmetry. Finally, this article aims to refute technocracy as an instrument of power in health regulations, thereby achieving the greatest democratic potential of Anvisa's regulations.

A influência da resposta dos EUA à COVID-19 no contexto da Saúde Global / The influence of the U.S. response to COVID-19 in Global Health

Resumo A resposta americana à pandemia envolve um proeminente volume de recursos federais, em especial destinados ao desenvolvimento e aquisição de produtos no uso interno, como diagnósticos ou vacinas. As justificativas para esse desembolso se baseiam em mecanismos de investimentos e aspectos históricos. Assim, a construção social do nacionalismo na formação na sociedade americana prejudica o acesso a tecnologias em saúde. A revisão desses aspectos demonstra como os Estados Unidos (EUA) garantiram compra de grande quantitativo de produtos em potencial, inclusive assegurando excessiva produção local. Essa política externa unilateral tem influenciado outros países ou blocos regionais e prejudicado a cooperação e a solidariedade global com impacto na saúde coletiva de diversas nações.

Abstract The American response to the pandemic involves a prominent volume of federal resources, especially for developing and acquiring products for internal use, such as diagnostics or vaccines. Investment mechanisms and historical aspects justify this expenditure. Thus, the social construction of nationalism in American society hinders access to health technologies. The review of such aspects shows how the United States (U.S.) secured a large number of potential products, ensuring excessive local production. This unilateral foreign policy has influenced other countries or regional blocs and undermined global cooperation and solidarity, affecting the collective health of several nations.

Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries / Utilización de decisiones de autoridades regulatorias de otras jurisdicciones para aprobar nuevos productos medicinales en países de América Latina y el Caribe / Uso de decisões regulatórias de outras jurisdições para aprovação de novas especialidades farmacêuticas em países da América Latina e Caribe

ABSTRACT Objective. To describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries' regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are considered as trusted regulatory authorities to rely on. Methods. Websites from LAC regulators were searched to identify the official regulations to approve new drugs. Data collection was carried out in December 2019 and completed in June 2020 for the Caribbean countries. Two independent teams collected information regarding direct recognition or abbreviated processes to approve new drugs and the reference (trusted) regulators defined as such by the corresponding national legislation. Results. Regulatory documents regarding marketing authorization were found in 20 LAC regulators' websites, covering 34 countries. Seven countries do not accept reliance on foreign regulators. Thirteen regulatory authorities (Argentina, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay, and the unique Caribbean Regulatory System for 15 Caribbean States) explicitly accept relying on marketing authorizations issued by the European Medicines Agency, United States Food and Drug Administration, and Health Canada. Ten countries rely also on marketing authorizations from Australia, Japan, and Switzerland. Argentina, Brazil, Chile, and Mexico are reference authorities for eight LAC regulators. Conclusions. Regulatory reliance has become a common practice in the LAC region. Thirteen out of 20 regulators directly recognize or abbreviate the marketing authorization process in case of earlier approval by a regulator from another jurisdiction. The regulators most relied upon are the European Medicines Agency, United States Food and Drug Administration, and Health Canada.

RESUMEN Objetivo. Describir el estado actual de la utilización de las decisiones de autoridades regulatorias de otras jurisdicciones en América Latina y el Caribe mediante la evaluación de los marcos regulatorios nacionales para la aprobación de nuevos medicamentos y establecer los organismos regulatorios extranjeros que se consideran autoridades regulatorias confiables para cada país. Métodos. Se realizaron búsquedas en los sitios web de las autoridades regulatorias de América Latina y el Caribe para identificar las regulaciones oficiales para la aprobación de nuevos medicamentos. La recopilación de datos se llevó a cabo en diciembre del 2019 y se completó en junio del 2020 para los países del Caribe. Dos equipos independientes recopilaron información sobre el reconocimiento directo o los procedimientos abreviados para la aprobación de nuevos medicamentos y los autoridades regulatorias de referencia (confiables) así definidos en la legislación nacional correspondiente. Resultados. Se encontraron documentos regulatorios sobre la aprobación de nuevos productos en los sitios web de veinte organismos regulatorios de América Latina y el Caribe, que abarcaban 34 países. Siete países no aceptan la utilización de decisiones de autoridades regulatorias extranjeras. Trece autoridades regulatorias (Argentina, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, México, Panamá, Paraguay, Perú, República Dominicana, Uruguay y el sistema regulador único para quince Estados del Caribe) aceptan de manera explícita confiar las decisiones para aprobación de nuevos medicamentos emitidas por la Agencia Europea de Medicamentos, la Administración de Alimentos y Medicamentos de Estados Unidos y Salud Canadá. Diez países aceptan también utilizar las autorizaciones para la comercialización de Australia, Japón y Suiza. Argentina, Brasil, Chile y México son autoridades de referencia para ocho autoridades regulatorias en la región. Conclusiones. La utilización de las decisiones de autoridades regulatorias de otras jurisdicciones se han convertido en una práctica común en América Latina y el Caribe. Trece de veinte autoridades regulatorias reconocen directamente o abrevian el proceso de aprobación de nuevos medicamentos en caso de que hayan recibido previamente la aprobación por parte de un organismo regulatorio de otra jurisdicción. La Agencia Europea de Medicamentos, la Administración de Alimentos y Medicamentos de Estados Unidos y Salud Canadá son las autoridades regulatorias de otras jurisdicciones en las cuales los reguladores de América Latina y el Caribe confían más.

RESUMO Objetivo. Descrever a prática atual de uso de decisões regulatórias de outras jurisdições na América Latina e no Caribe (ALC) mediante avaliação os marcos regulatórios dos países para aprovação de novos medicamentos e verificar, para cada país, quais entidades reguladoras estrangeiras são consideradas autoridades reguladoras de confiança por cada país. Métodos. Foi realizada uma pesquisa nos sites das autoridades reguladoras da ALC para identificar as regulamentações oficiais para aprovação de novos medicamentos. A coleta de dados foi feita em dezembro de 2019 e concluída em junho de 2020 para os países do Caribe. Dois grupos independentes coletaram informações sobre o reconhecimento direto ou o procedimento abreviado para aprovação de novos medicamentos e as autoridades reguladoras de referência (de confiança) definidas como tal pela respectiva legislação nacional. Resultados. Documentos regulatórios relacionados à aprovação de novos produtos foram obtidos de 20 sites de órgãos reguladores da ALC, abrangendo 34 países. Sete países não admitem o uso de decisões regulatórias de entidades reguladoras externas. Treze autoridades reguladoras (na Argentina, Colômbia, Costa Rica, El Salvador, Equador, Guatemala, México, Panamá, Paraguai, Peru, República Dominicana, Uruguai e o Sistema Regulador do Caribe unificado para 15 Estados caribenhos) admitem explicitamente a admissibilidade de decisões regulatórias para aprovação de novos medicamentos de outras jurisdições, quais sejam: Agência Europeia de Medicamentos (EMA), Agência Reguladora de Alimentos e Medicamentos (FDA) dos EUA e Health Canada. Dez países também aceitam decisões para autorização de comercialização da Austrália, Japão e Suíça. Argentina, Brasil, Chile e México são autoridades de referência para oito agências reguladoras. Conclusões. O uso de decisões regulatórias de outras jurisdições tornou-se prática comum na América Latina e Caribe. Treze das 20 agências reguladoras reconhecem diretamente ou abreviam o procedimento de aprovação de novos medicamentos no caso de tal aprovação já haver sido concedida por uma autoridade reguladora de outra jurisdição. A EMA, a FDA e a Health Canada são as autoridades estrangeiras nas quais as agências reguladoras da América Latina e Caribe mais confiam.

Duración de la gestión ministerial y logros en salud en el Perú / Length of ministerial tenure and public health achievements in Peru

Los periodos breves en la gestión de un ministerio de salud pueden poner en riesgo la implementación y la efectividad de políticas de Estado por cambios en la orientación de la gestión, por un proceso natural de aprendizaje, o por otros factores. El propósito de este artículo fue determinar y comparar la duración de la gestión ministerial en salud en Perú, describir sus características y discutir su relación con los logros en salud pública. Entre 1935 y 2021, la media de duración de la gestión fue de 13,7 meses y la mediana fue de 11 meses, siendo la más extensa de 67 meses, de Constantino Carvallo, y la más breve de un día, de Javier Correa. La duración de la gestión ministerial en el Perú tiene un amplio rango de variación (1día hasta 67 meses), es menor comparada con la de otros países, y está disminuyendo desde el 2016. Si bien, una duración mayor a la encontrada no sería suficiente para garantizar los logros en salud, podría contribuir en el sostenimiento de las acciones de salud y tener un efecto positivo en las políticas de largo plazo.

Short administration periods of a health ministry can jeopardize the implementation and effectiveness of state policies due to changes in management orientation, altering the natural learning process, or other factors. The aim of this article was to determine and compare the tenure length of the ministry of health in Peru, describe its characteristics and discuss its relationship with public health achievements. Between 1935 and 2021, the average tenure was of 13,7 months and the median was 11 months, the longest was found to be 67 months, by Constantino Carvallo, and the shortest was one day, by Javier Correa. The length of ministerial tenure in Peru has a wide range of variation (1 day up to 67 months), it is shorter compared to that of other countries and is decreasing since 2016. Although longer tenures would not be sufficient to guarantee health achievements, it might contribute to the sustainability of health-related actions and have a positive effect on long-term policies.

Ethical and Legal Considerations for the Inclusion of Underserved and Underrepresented Immigrant Populations in Precision Health and Genomic Research in the United States.

There has been growing recognition of the importance of diversity and inclusion of underrepresented minority populations, including immigrants, in genomic research and precision medicine. Achieving diversity has been difficult and has led some scholars to question whether the law is a help or a threat to the inclusion of underserved and underrepresented immigrant populations. In this commentary, I provide an overview of some of the many relevant legal issues affecting the inclusion of immigrants in genomic research and precision health initiatives, such as the All of UsSM Research Program. Development of research recruitment, retention, and data collection plans without also considering the legal and sociopolitical context within which such efforts are to be carried out is risky. Advancing health policy with a goal of eliminating health disparities (or, at a minimum, ensuring that health disparities are not exacerbated by genomic or precision health technologies) requires us to acknowledge the negative effects that immigration policy and criminal justice policy have on the involvement of immigrants in such research and on their health directly. I conclude that it is not a question of whether the law is a help or a threat but, rather, whether we collectively will prioritize authentic diversity and inclusion policies and also insist on compliance with the laws intended to ensure the human right of every individual - regardless of immigration status or national origin - to share in the advancement of science.

Registro y entrega de licencias de medicamentos - Áreas y conceptos claves: síntesis rápida de evidencia de alcance / Registration and delivery of drug licenses - Areas and key concepts: rapid synthesis of scoping evidence

ANTECEDENTES Y OBJETIVO Una Agencia Reguladora Nacional de Medicamentos es una entidad que se encarga de la regulación de 4 funciones básicas: Registro de productos, Entrega de licencias, Inspección y Vigilancia, y Control de precios. Sin embargo, no todos los países cuentan con una organización que reúna las 4 funciones aquí detalladas. En esa línea, Chile ha creado un grupo técnico para la creación y acreditación de esta agencia, de manera de contar con algunas ventajas en términos de barreras arancelarias. Esta agencia velaría por la alta calidad de los medicamentos utilizados en el país. En este contexto el Coordinador del Grupo Técnico Asesor para el Directorio del Sistema Nacional de Regulación, control y vigilancia de medicamentos solicita esta síntesis de evidencia con el objetivo de informar a la toma de decisiones respecto del impacto de contar con una Agencia Nacional de Regulación de Medicamentos. METODOLOGÍA Utilizando palabras clave como "Registro", "Medicamentos", "Política farmacéutica", "Regulación", "Autoridades reguladoras" y "Licencias" se buscó en las bases de datos Cochrane Library, PDQ y Health System Evidence No se restringió el tipo de estudio buscado ni los años de realización. Se realizaron búsquedas por Título y Abstract. RESULTADOS El resumen utiliza 13 estudios Los problemas identificados en la literatura que podrían estar relacionados a registro y entrega de licencias son: Medicamentos falsificados y adherencia a tratamientos Los ámbitos/áreas de interés encontrados en la literatura son: Medicinas esenciales, uso de genéricos y sistemas de información Por último, intervenciones comúnmente mencionadas en la literatura, y que podrían estar asociadas a registro y entrega de licencias para medicamentos son: Lista de fármacos preferidos, monitoreo de fármacos de interés particular y proceso de autorización de fármacos.

The immunisation programme in the Caribbean.

PIP: The Directing Council of Pan American Health Organization approved a resolution concerning the formal inauguration of the Expanded Programme on Immunization (EPI) in the Americas in October 1977. Subsequently, the EPI entered full implementation in those countries that were members of the Caribbean Epidemiology Center (CAREC) during 1978-80. All 19 CAREC Member Countries (CMC) were conducting routine immunization with diphtheria, pertussis, tetanus, poliomyelitis, measles and BCG vaccines by 1980. The establishment of the program in these countries resulted in focused activities, including training and the development of operational guidelines. Health education has been primarily used to encourage mothers to have their children vaccinated at optimum age, and to advise parents and guardians about adverse reaction to vaccines. Great efforts have been made in immunization coverage in all the CMCs for the six vaccine preventable diseases. The eradication of poliomyelitis, the interruption of measles transmission (8 years measles-free), and the implementation of strategies for the elimination of rubella and CRS have presented many challenges to public health practitioners in the region. The success of all these initiatives is a reflection of the deep commitment and strong partnerships, which have been developed between the governments, health practitioners, and people of the region. Moreover, technical and financial support from both international agencies and service clubs played a major role in the success of the program.^ieng

Approaches to control sexually transmitted diseases in Haiti, 1992-95.

Despite major obstacles, activities to control sexually transmitted diseases (STDs) were initiated in Haiti in 1992 in collaboration with local nongovernmental organizations. The approaches included review of available local data, assessment of STD case management practices and constraints, and development of specific STD control activities at the primary health care level, such as systematic screening of all pregnant women for syphilis and improved comprehensive syndrome-based STD case management. The activities included conduct of local studies, presentation and dissemination of results to key audiences, training of health care providers, improvement of local capacities, and consensus-building on implementation of STD control approaches. STD awareness and case management improved considerably; for example, 69% of the clinicians interviewed reported correct STD treatments in the north-eastern primary health care centres in 1995, compared with < 10% in 1992. At the end of the project, national STD case management guidelines were developed by consensus between the various organizations and the Ministry of Health. Lessons learned included the importance of local data generation and of communication and collaboration with various institutions for consensus-building, the need for continued training, and field supervision to ensure behaviour change among STD care providers. A national STD control programme should be implemented as soon as possible in both the public and private sector. External funding will remain critical to control this important public health problem in Haiti.

PIP: Mid-1992 was a time of considerable political and socioeconomic instability in Haiti. Haiti's first democratically elected president had been ousted by a military junta and both political crimes and human rights abuses abounded. No national sexually transmitted disease (STD) control program was in place and almost no data were available on the magnitude and scope of STDs in the country. In this context, and despite many obstacles, STD control activities were planned with the hope of eventually developing a national STD control program. US Agency for International Development-funded AIDSCAP HIV/AIDS/STD prevention initiatives were first launched in Haiti in mid-1992 in collaboration with local nongovernmental organizations (NGOs). Direct collaboration with the de facto government was not allowed until democracy was restored in October 1994. The authors describe the STD control approaches and interventions initiated under these circumstances, with lessons learned for potential application outside of Haiti. Approaches included a review of available local data, an assessment of STD case management practices and constraints, and the development of specific STD control activities at the primary health care level, such as the systematic screening of all pregnant women for syphilis and improved comprehensive syndrome-based STD case management. Local studies were conducted, with the salient results presented to key audiences; health care providers were trained; local capacities improved; and consensus built upon the implementation of STD control approaches. STD awareness and case management improved considerably, with national STD case management guidelines developed at the end of the project through consensus between various organizations and the Ministry of Health.

Integrating gender into natural resources management projects: USAID lessons learned.

PIP: This article discusses USAID's lessons learned about integrating gender into natural resource management (NRM) projects in Peru, the Philippines, and Kenya. In Peru, USAID integrated women into a solid waste management project by lending money to invest in trash collection supplies. The loans allowed women to collect household waste, transfer it to a landfill, and provide additional sanitary disposal. The women were paid through direct fees from households and through service contracts with municipalities. In Mindanao, the Philippines, women were taught about the health impact of clean water and how to monitor water quality, including the monitoring of E. coli bacteria. Both men and women were taught soil conservation techniques for reducing the amount of silt running into the lake, which interferes with the generation of electricity and affects the health of everyone. The education helped women realize the importance of reducing silt and capitalized on their interest in protecting the health of their families. The women were thus willing to monitor the lake's water quality to determine if the conservation efforts were effective. In Kenya, USAID evaluated its Ecology, Community Organization, and Gender project in the Rift Valley, which helped resettle a landless community and helped with sustainable NRM. The evaluation revealed that women's relative bargaining power was less than men's. Organized capacity building that strengthened women's networks and improved their capacity to push issues onto the community agenda assured women a voice in setting the local NRM agenda.^ieng

Local initiatives: USAID / Peru supports national legislation on domestic violence.

PIP: This brief article describes the activities of USAID-funded groups that promote gender equality and the protection of women and children against domestic violence in Peru. The Peruvian legislature passed Public Law 26260 in 1993, which addresses the issue of domestic violence. The Movimiento Mujers Peruanas Manuela Ramos received support from USAID to develop a registration, protection, redress, and referral system for women who suffer domestic violence. A campaign was conducted that used leaflets and radio and television to educate women about the new law and their rights under it. USAID also supported the Ombudsman's Office for Women. This office instituted a national study on domestic violence that will provide a database for monitoring reductions in domestic violence expected from the new law and the campaign. ReproSalud has a reproductive health project that USAID is funding. This group as well as 18 other groups function under an umbrella group, the Manuela Ramos. The target is poor women living in disadvantaged rural and urban areas, who are at greater risk of domestic violence. Manuela Ramos conducted participatory, qualitative research that helps women rank their reproductive health needs. All 18 organizations found domestic violence to be a reproductive health problem. One organization identified it as the most serious problem, and one that contributes to complications during delivery. Manuela Ramos works to make men more aware of the negative impact that domestic violence has on women.^ieng

Improving maternal health.

PIP: In Bolivia, 50% of pregnant women experience pregnancy and childbirth without any medical attention. Bolivia has the highest rate of maternal mortality in South America. Family planning programs not only teach women about the benefits of spacing children several years apart, breast feeding, good nutrition, prenatal and postpartum visits, and safe deliveries, they also reduce the incidence of abortion, help to alleviate poverty and contribute to the economic stability of a country. The government, nongovernmental organizations, and the medical community therefore joined forces to launch a nationwide family planning campaign in Bolivia. The US Agency for International Development has provided Bolivia with financial and technical assistance to establish a network of primary health care clinics. The author, US First Lady, visited one of the clinics during her trip to participate in the Sixth Conference of Wives of Heads of State and Government of the Americas. The US Congress recently slashed funds for international family planning program assistance by 35% and added restrictions on the delivery schedule of aid for the first 9 months of the fiscal year. Similarly harsh cuts and delays are included in the current budget. A recent analysis by five population organizations found that these funding cuts will result in 1.6 million more abortions, more than 8000 maternal deaths, and 134,000 infant deaths in developing countries. Policymakers must be made to understand that family planning campaigns in operation in Bolivia and elsewhere are sensible, cost-effective, and long-term strategies for improving women's health, strengthening families, and lowering abortion rates.^ieng

GO-NGO collaboration in FP programs.

PIP: JOICFP has conducted the Seminar on Family Planning Administration for Senior Officers II regularly since 1967, providing training in family planning to 1151 participants in more than 70 countries over the period. 16 representatives from governmental (GO) and nongovernmental organizations (NGOs) from Bangladesh, Ghana, Indonesia, Jordan, Mexico, Nepal, the Philippines, and Tanzania attended the 1997 seminar, held in Japan from August 25 through September 12. It was the first time that one representative each of a GO and an NGO from each country attended the training course. GO-NGO collaboration was emphasized throughout the seminar with the goal of fostering better GO-NGO working relationships. Participants were provided with background on the promotion of family planning and maternal and child health (FP/MCH) in Japan from postwar times up to the present and the role played by GO-NGO collaboration in the success of these activities and the preventive healthcare movement in general. The other major theme of the event was the development of strategies to achieve the self-reliance of programs such as the community-based promotion of integrated programs. Excerpts are presented from interviews with 3 participants.^ieng

Can AIDS drugs be afforded?

PIP: UNAIDS has launched an 'HIV Drug Access Initiative' in the Ivory Coast, Uganda, Chile, and Vietnam; the pilot project will attempt to improve access to HIV drugs. Public and private sector efforts will be coordinated. The Glaxo Wellcome, Hoffman-La Roche, and Virco pharmaceutical companies will participate. Each country will 1) adapt its present system with regard to HIV and 2) establish both an HIV drug advisory board and a non-profit company which will import the drugs. Health ministries within each country will be required to find sources of funding for the programs. Uganda will probably use funds from its sexually transmitted disease (STD) program, which is supported by the World Bank; the Ivory Coast will combine corporate contributions, new tariffs, and non-profit insurance system monies into a 'solidarity fund.' UNAIDS funds will be used for oversight and evaluation. UNAIDS also released a review of 68 studies which examined the impact of sex education on the sex behavior of young people; it indicated that, in 65 of the studies, sex education did not increase the sexual activity of youth. UNAIDS concluded that quality programs helped delay first intercourse and often reduced the number of sexual partners, resulting in reduced rates of STDs and unplanned pregnancy. UNAIDS further concluded that effective sex education should begin before the onset of sexual activity, and curriculums should be focused. Openness in communicating about sex should be encouraged, and social and media influences on behavior should be addressed. Young people should be taught negotiating skills (how to say 'no' to sex and how to insist on safer sex).^ieng

Hillary Clinton visits Pathfinder projects in Brazil.

PIP: In October 1995, US First Lady Hillary Clinton visited a maternity hospital in Salvador, Brazil, in which a family planning (FP)/reproductive health program has been administered by Pathfinder International since 1981 with funding from USAID. During her tour of the facility, Clinton learned about the high degree of unmet need for FP in the region which results from a lack of sufficient resources to meet demand. Clinton, in turn, praised the state of Bahia for its emphasis on FP in low-income areas.^ieng

Dominican NGOs move from competition to collaboration.

PIP: In 1992, the seven nongovernmental organizations (NGO) working to prevent HIV/AIDS in the Dominican Republic received most of their funding and technical assistance from the US Agency for International Development (USAID). In September 1992, however, USAID's AIDSTECH project asked the AIDS Control and Prevention (AIDSCAP) Project to prepare the NGOs for the time when USAID would no longer be their main source of support. To that end, AIDSCAP worked with NGO staff to assess their technical, managerial, and administrative needs, and identified a lack of administrative and managerial experience among many NGO staff. AIDSCAP therefore developed an institutional strengthening plan, including a series of capacity building workshops, in 1993. Many NGOs, however, foreseeing the impending need to compete with other NGOs for limited funds, were not interested in sharing ideas and working together. This article describes how Coordinadora de Animacion Socio-Cultural (CASCO) and the Instituto Dominicano de Desarrollo Integral (IDDI) competed in the context of uncertainty over continued donor funding, but now meet regularly to coordinate HIV/AIDS prevention projects for youth in the Dominican Republic.^ieng

Breastfeeding. COTALMA: training health professionals.

PIP: The Comite Tecnico de Apoyo a la Lactancia Materna (COTALMA), the Technical Breastfeeding Support Committee, was founded in Bolivia in 1989. It is financed by the United States Agency for International Development (USAID) and the United Nations Children's Fund (UNICEF). It is administered in coordination with the Ministry of Health (MOH). MOH and UNICEF choose the hospitals, who send teams that include a pediatrician, a gynecologist, a nurse, and a nutritionist. The first phase of the course (5.5 days) covers the scientific background of breastfeeding. A baseline study is then planned and conducted at each hospital. 2 to 3 months later, the second phase takes place during which data is presented and breast feeding programs are developed for each hospital. Communication, training, counseling, and planning and evaluation are covered. Practicums are conducted at hospitals. Trainers are usually members of COTALMA. The person in charge of maternal and child health services at MOH lectures on national health policies concerning mothers and children. Training includes use of the national health card, breastfeeding and child survival, and breastfeeding as a family planning method. Culturally appropriate course materials, which are in Spanish, are adapted from those developed by Wellstart International. Articles by COTALMA members and others are added. Participants are encouraged to train all staff at their institutions.^ieng

AIDSCAP policy dialogue in Honduras: establishing the politics of prevention. Policy profile.

PIP: Two meetings were held in August 1993 in Honduras to deliver results of assessments of the potential impact of HIV/AIDS in Tegucigalpa, the capital (where 12% of adults may be infected with HIV by 2000), and San Pedro Sula, Honduras's largest industrial city (where 17% of adults are expected to be infected), and to spark a national dialogue about the need to slow the spread of the epidemic. The economic impact will be great because most of those affected will be workers 20-30 years old. AIDS treatment costs families approximately 14 months of an average Honduran's income and AIDS illness and premature death diminishes an individual's potential income by almost two-thirds. The tools used in the Honduran analysis by AIDSCAP were mathematical modeling of the epidemic, economic impact assessments, and creation of policy dialogue. AIDSCAP trained Ministry of Health employees to gather data, which were modeled using the computer programs EIPMODEL, DemProj, and AID. Data were presented in a way to stimulate dialogue among policy makers, the media, and international donors. Initial meetings were chaired by the president and first lady of Honduras, and this initial dialogue led to the creation of CONALSIDA (Comision de Alto Nivel de Apoyo en La Lucha Contra el SIDA), a high-level AIDS policy-making body to be chaired by the first lady. This generated extensive coverage in the newspapers and on television news and talk shows. Because this initial effort will not sustain development of the necessary positive policy environment, AIDSCAP is developing ways to disseminate the information to a wider audience.^ieng

[ABEPF: honest work and the battle against obstacles]. / ABEPF: trabalho honesto e luta contra obstaculos.

PIP: The 1988 Brazilian Constitution defined the right of married individuals to family planning (FP). In 1981 ABEPF (the Brazilian Association of Family Planning Entities) was established in order to unite the private entities that were engaged in FP work. ABEPF has been working in a responsible manner without profit since then, and has earned the right to be granted the title of public federal utility. However, it is paradoxically because of its FP work that ABEPF is not given this title. The opponents of FP continue to obstruct the realization of Paragraph 7 of Article 226 of the Constitution. Public federal utility is an extremely important appellation because of the benefits and status conferred. ABEPF is already recognized as a public utility in the state of Rio de Janeiro. Previous attempts to acquire the title were turned down without justification by Dr. Zilda Arns, the director of CNBB. Then, the director of ABEPF and Dr. Zilda Arns met on December 7, 1992, when another application looked more promising. However, it was vetoed again, with Arns claiming that ABEPF might potentially become a proabortion body. In reality, those who refuse to help a broad, safe, and responsible FP program are themselves accountable for the high abortion rate. With its hypothetical arguments about the potential proabortion image of ABEPF, the representative of CNBB in the Ministry of Health arrogates the right to create all kinds of obstacles to preclude ABEPF from getting this title. While this obstruction continues, hundreds or thousands of fake organizations have falsely benefitted from public resources, and those who have created the obstacles have not done anything against this pattern. The issue here is the destiny of FP and the population policy of this country, because the federal authorities do not want a confrontation with the bishops.^ieng

New family planning center serves 60,000 Nicaraguans.

PIP: In Nicaragua, the recently opened Regional Family Planning (FP) Center in the capital of Chontales Province provides a variety of FP services to the 60,000 citizens of Juigalpa. These services include counseling, laboratory exams, gynecologic exams, and voluntary sterilization. the Asociacion Pro Bienestar de la Familia Nicaraguense (PROFAMILIA) opened the center, since FP services have been neglected in this province as compared to access to these services in the large population centers of Managua and Leon. A recent contraceptive prevalence survey shows that contraceptive prevalence in urban areas of Nicaragua is 62%, while it is just between 13-15% in rural regions, like Chontales and Zelaya. The center will also run a community distribution program for Chontales. As of May 1993, it had 25 community distribution posts in the region, providing contraceptives and training volunteers. PROFAMILIA hopes to open another regional center in Chinandega in the western part of Nicaragua in 1993. It plans on opening a central clinic in Grenada, the third largest city, to serve 120,000 people from Grenada and the small communities surrounding Grenada.^ieng

Preventing HIV transmission in "priority" countries.

PIP: A recent $168 million 5-year cooperative agreement funded by the US Agency for International Development combines elements of its earlier AIDSTECH and AIDSCOM projects under the AIDS Control and Prevention Project (AIDSCAP). Instead of working to effect broad-scale behavior change toward the prevention of HIV transmission, AIDSCAP strategically targets locations for condom distribution, behavior change messages, and the treatment of sexually transmitted diseases. In Lagos and the states of Cross River and Jigawa where the AIDS epidemic is firmly established, for example, AIDSCAP is intervening to increase condom demand and accessibility; alter sexual behaviors which carry a high risk for HIV transmission; and reduce the prevalence of STDs which enhance the transmission of HIV. The project began in fall of 1991 and has expanded to include Ethiopia, Kenya, Malawi, Nigeria, Rwanda, Senegal, Brazil, Haiti, Jamaica, India, and Thailand; limited assistance is also provided to 7 other African countries, 4 Latin America countries, and 1 in Asia. 4 more countries are in the final stages of negotiations to be included in the project. The USAID mission in the host country and the government must invite AIDSCAP involvement in order for the country to attain priority status. Countries are selected based on the HIV prevalence rate, population size and distribution, level of commitment to HIV prevention/control, capacity to respond to the AIDSCAP plan of action, level of other donor support, the USAID Mission's development priorities, and the Mission's commitment of substantial funds from its own budget. Once involved, AIDSCAP is mandated to implement interventions through in-country agencies.^ieng