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AbstractIn this article, we examine three different cases in which health activists lobbied the World Health Organization and its member states to regulate the marketing practices of multinational companies. The campaign against tobacco manufacturers resulted in a binding treaty; the campaign against manufacturers of infant formula resulted in a non‐binding code of conduct; and the campaign against pharmaceutical manufacturers failed. We show that existing arguments regarding the success of global social movements and transnational advocacy networks fail to explain the divergent outcomes in these three cases. Instead, we argue that the effectiveness of global advocacy in these cases depended on the level of perceived legitimacy of the knowledge supporting the advocates' claims and on the prestige of the experts participating in the campaigns.

Our aim was to systematically identify and compare how generic medications, as defined by the US Food and Drug Administration (FDA), World Health Organization (WHO), and European Medicines Agency (EMA), are classified and defined by regulatory agencies around the world. We focused on emerging markets and selected the most populated countries in each of the WHO regions: Africa, the Americas, Eastern Mediterranean, Europe, Southeast Asia, and Western Pacific. A structured review of published literature was performed through December 2013. Direct information from regulatory agencies and Ministries of Health for each country was extracted. Additionally, key informant interviews were performed for validation. Of the 21 countries selected, approximately half provided an official country-level definition for generic pharmaceuticals. The others did not have any definition or referred to the WHO. Only two-thirds of the countries had specific requirements for generic pharmaceuticals, often associated with clinical interchangeability. Most countries with requirements mention bioequivalence, but few required bioavailability studies explicitly. Over 30% of the countries had other terms associated with generics in their definitions and processes. In countries with generic drug policies, there is reference to patent and/or data protection during the drug registration process. Several countries do not mention good manufacturing practices as part of the evaluation process. Countries in Africa and Eastern Mediterranean regions appear to have a less developed regulatory framework. In summary, there is significant variability in the definition and classification of generic drugs in emerging markets. Standardization of the definitions is necessary to make international comparisons viable.

Our aim was to systematically identify and compare how generic medications, as defined by the US Food and Drug Administration (FDA), World Health Organization (WHO), and European Medicines Agency (EMA), are classified and defined by regulatory agencies around the world. We focused on emerging markets and selected the most populated countries in each of the WHO regions: Africa, the Americas, Eastern Mediterranean, Europe, Southeast Asia, and Western Pacific. A structured review of published literature was performed through December 2013. Direct information from regulatory agencies and Ministries of Health for each country was extracted. Additionally, key informant interviews were performed for validation. Of the 21 countries selected, approximately half provided an official country-level definition for generic pharmaceuticals. The others did not have any definition or referred to the WHO. Only two-thirds of the countries had specific requirements for generic pharmaceuticals, often associated with clinical interchangeability. Most countries with requirements mention bioequivalence, but few required bioavailability studies explicitly. Over 30% of the countries had other terms associated with generics in their definitions and processes. In countries with generic drug policies, there is reference to patent and/or data protection during the drug registration process. Several countries do not mention good manufacturing practices as part of the evaluation process. Countries in Africa and Eastern Mediterranean regions appear to have a less developed regulatory framework. In summary, there is significant variability in the definition and classification of generic drugs in emerging markets. Standardization of the definitions is necessary to make international comparisons viable.

We determine whether community pharmacies in Bogotá produce differential quality signals, and if they are related to an objective quality measure: the compliance with prescription rules. In this quantitative descriptive study, we use the simulated client methodology (N=298) to assess whether Bogota's community pharmacies comply with prescription rules related to contraceptive medications. We find that one per cent of the staff at the pharmacy asked for a prescription when the pills were requested. Five per cent of the staff asked additional questions that signal knowledge or interest in the correct delivery of pills. We do not find differences by socio-economic level or type of pharmacy ownership (i.e., large firm versus independent) regarding the request of prescriptions or further questions about the pills. Concerning the aesthetic signals of quality, independent pharmacies were less likely to display a diploma of their chemist, and the likelihood that their staff wore white coats was also lower. We conclude that Bogota's community pharmacies differentiation is based on simple signals associated with a professional image, but not with actual procedures that guarantee the safety of consumers.

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.

On June 2, 2021, the Colombian Ministry of Health and Social Protection, through Resolution No. 777, laid down the requirements to resume all restricted economic and social activities. Similarly, said Resolution established the Municipal Epidemiological Resilience Index (IREM by its acronym in Spanish) as a tool to support decision-making regarding this economic reactivation amid the third epidemic peak of COVID-19 in the country. The purpose of this article is to perform a critical analysis of the technical aspects of the IREM and to explore the feasibility of its implementation as a support for the resumption of economic and social activities as proposed in the Resolution. The present critical analysis emphasizes on the lack of a clear definition of epidemiological resilience that is consistent with the scientific literature. Furthermore, the face and content validity of the index, as well as the construct validity of the index and of its dimensions, are called into question and, therefore, the feasibility of using it to determine said resumption. ; El 2 de junio de 2021, el Ministerio de Salud y Protección Social de Colombia expidió la Resolución 777, mediante la cual se determinan las condiciones para el reinicio de todas las actividades económicas y sociales restringidas. Asimismo, en esta resolución se define el Índice de resiliencia epidemiológica municipal (IREM) como la herramienta para apoyar la toma de decisiones relacionadas con esta reactivación económica en medio del tercer pico epidémico de la COVID-19 en el país. El objetivo de este artículo es hacer un análisis crítico de los aspectos técnicos del IREM y explorar la conveniencia de su implementación como soporte del reinicio de las actividades económicas y sociales propuesto en la resolución. Dentro de este análisis crítico se destaca la falta de una clara definición de resiliencia epidemiológica que se ajuste a la literatura científica. Además, se cuestiona tanto la validez de apariencia, contenido y constructo del índice global, como la validez del constructo de sus dimensiones y, por tanto, la pertinencia de usarlo como herramienta para definir dicho reinicio.