Institutional change and political decision-making in the creation of the Brazilian National Health Surveillance Agency

Piovesan, Márcia Franke; Labra, Maria Eliana

doi:10.1590/s0102-311x2007000600012

Cited by 11 publications

(6 citation statements)

References 3 publications

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“…The national regulator, ANVISA, was created in 1999, in the context of scandals over falsified and unsafe medicines. With the strong support of the MoH, Congress approved the creation of ANVISA as an independent agency, a model that grants it administrative and financial independence, and the stability of its directors ( Piovesan and Labra, 2007 ). Since the late 1990s, the MoH and ANVISA have reformed what had been a corrupt and inefficient drug regulation system, such that Brazil's regulatory structure is regarded as the most stringent in Latin America ( Pan American Health Organization, 2021 ).…”

Section: Contextualizing Brazil's Response To Covid-19mentioning

confidence: 99%

The politics of COVID-19 vaccination in middle-income countries: Lessons from Brazil

Fonseca

Shadlen

Bastos

2021

Social Science & Medicine

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Section: Contextualizing Brazil's Response To Covid-19mentioning

confidence: 99%

The politics of COVID-19 vaccination in middle-income countries: Lessons from Brazil

Fonseca

Shadlen

Bastos

2021

Social Science & Medicine

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“…The National Agency for Health Surveillance (ANVISA; the Brazilian equivalent of the US Food and Drug Administration) was set up in 1999 as an autonomous body to regulate on a broad range of matters: medicines and health technologies, environment, food, health services, and frontiers. 36 Effi cient action in many diff erent areas is proving to be a major challenge, as exemplifi ed by control of drugs. High treatment coverage for key infections such as HIV/AIDS, tuberculosis, and leprosy has been achieved, with exclusive distribution of free drugs through the SUS on the basis of protocols derived through expert consensus.…”

Section: Regulation and Drugsmentioning

confidence: 99%

Health conditions and health-policy innovations in Brazil: the way forward

et al. 2011

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Brazil is a large complex country that is undergoing rapid economic, social, and environmental change. In this Series of six articles, we have reported important improvements in health status and life expectancy, which can be ascribed largely to progress in social determinants of health and to implementation of a comprehensive national health system with strong social participation. Many challenges remain, however. Socioeconomic and regional disparities are still unacceptably large, refl ecting the fact that much progress is still needed to improve basic living conditions for a large proportion of the population. New health problems arise as a result of urbanisation and social and environmental change, and some old health issues remain unabated. Administration of a complex, decentralised public-health system, in which a large share of services is contracted out to the private sector, together with many private insurance providers, inevitably causes confl ict and contradiction. The challenge is ultimately political, and we conclude with a call for action that requires continuous engagement by Brazilian society as a whole in securing the right to health for all Brazilian people.

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“…Brazil is the second largest emerging pharmaceutical market in the world ( 28 ). The country’s agency (ANVISA by its Portuguese abbreviation) was created in 1999 ( 29 ) and accepted as a member of the ICH in 2016 ( 28 ). ANVISA has received continuous political support to upraise the country’s regulatory capacities, including those that deal with their own appraisal of new drugs.…”

Section: Discussionmentioning

confidence: 99%

Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries

Durán¹,

Cañás²,

Urtasun³

et al. 2021

Rev Panam Salud Publica

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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.

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Institutional change and political decision-making in the creation of the Brazilian National Health Surveillance Agency

Abstract: This article examines the decision-making process that led to the creation of the Brazilian timeframe, 1998-1999) allowed the creation of the first regulatory agency in the social policies area in Brazil.

Cited by 11 publications

References 3 publications

The politics of COVID-19 vaccination in middle-income countries: Lessons from Brazil

The politics of COVID-19 vaccination in middle-income countries: Lessons from Brazil

Health conditions and health-policy innovations in Brazil: the way forward

Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries

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