Laboratory of Education and Research in In Vitro Toxicology - Tox In, Faculty of Pharmacy, Universidade Federal de Goiás, Goiânia, State of Goiás, Brazil.
Altern Lab Anim. 2019 May;47(2):71-81. doi: 10.1177/0261192919856806. Epub 2019 Jul 19.
In Brazil, efforts towards the regulatory acceptance and implementation of innovative methods to replace experimental animal use in various fields began to gather force in 2008, with the approval of (the Arouca Law). This law represented a milestone, as it created the National Council for the Control of Animal Experimentation (CONCEA) to deal with the ethical and legal issues related to the use of laboratory animals. In 2014, CONCEA put together a framework for expanding the implementation of non-animal methodologies for use in research and education. It also promoted the regulatory acceptance in Brazil of 24 test guidelines, including 15 approaches. It should be emphasised that, in Brazilian legislation, is generally based on the toxicological endpoint and not on the category of product, as tends to be the case in other countries (e.g. cosmetics in the European Union). The resolution-dependent deadlines for the obligatory replacement of methods with the CONCEA-approved tests are 2019 and 2021. Brazil has advanced considerably towards the replacement of animal experimentation, and in certain aspects, this has been in a highly progressive manner. However, there is still a lot of work to be done, especially considering the current political scenario with reduced investment in research, development and innovation. The chronology of significant events following the approval of the Arouca Law, which have contributed to the promotion of the Three Rs alternatives in Brazil, will be examined.
在巴西,2008 年通过了(阿罗卡法),这一举措为在各个领域用创新方法替代实验动物的监管审批和实施工作提供了助力,自此之后,这些工作开始大力推进。该法律是一个里程碑,它创建了国家实验动物管理和使用委员会(CONCEA),以处理与使用实验动物相关的伦理和法律问题。2014 年,CONCEA 制定了一个框架,旨在扩大非动物方法在研究和教育中的应用。它还推动了巴西对 24 项测试指南的监管审批,其中包括 15 种方法。应当强调的是,在巴西立法中,替代方法的审批通常基于毒理学终点,而不是产品类别,这与其他国家(例如欧盟的化妆品)的情况不同。根据决议,CONCEA 批准的测试必须在 2019 年和 2021 年之前强制替代现有的方法。巴西在替代动物实验方面取得了相当大的进展,在某些方面,这是非常进步的。然而,仍有许多工作要做,特别是考虑到当前的政治环境,研究、开发和创新的投资减少了。本文将考察阿罗卡法通过后,巴西促进替代方法的三个 R 原则的重大事件的时间顺序。