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[巴西的仿制药政策实施情况]

[Generic drug policy implementation in Brazil].

作者信息

Dias Cláudia Regina Cilento, Romano-Lieber Nicolina Silvana

机构信息

Faculdade de Saúde Pública, Universidade de São Paulo, São Paulo, Brasil.

出版信息

Cad Saude Publica. 2006 Aug;22(8):1661-9. doi: 10.1590/s0102-311x2006000800014. Epub 2006 Jul 7.

Abstract

A generic drug policy has been implemented in Brazil since 1999. Several political and administrative stages transpired between enactment of the legislation and the actual marketing and consumption of these drugs. This article describes the policy implementation process and examines the country's generic drug legislation, approved from 1999 to 2002. To contextualize these measures, the study compares articles published by two national periodicals and interviews with a government representative involved in drafting the legislation and a representative from the pharmaceutical industry. Generic drugs quickly gained considerable space in the Brazilian pharmaceutical market. Ongoing adaptation of the legislation, media support, and the government's involvement in spreading the policy were key success factors. The population's access to medicines did not increase significantly, but people can now purchase medicines at more affordable prices and with quality assurance and interchangeability.

摘要

自1999年以来,巴西实施了仿制药政策。从立法颁布到这些药物的实际销售和消费,经历了几个政治和行政阶段。本文描述了该政策的实施过程,并审视了1999年至2002年批准的该国仿制药立法。为了将这些措施置于背景中,该研究比较了两份国家期刊发表的文章,并采访了参与起草立法的政府代表和制药行业的一名代表。仿制药在巴西制药市场迅速获得了相当大的份额。立法的持续调整、媒体支持以及政府在推广该政策方面的参与是关键的成功因素。民众获得药品的机会并没有显著增加,但人们现在可以以更实惠的价格购买药品,并且药品有质量保证且可互换。

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