The creation of the legal system for generic medicines began with the introduction of Law Number 9787 in February 1999 (Brazil 1999).

There are differences in the presentation of the packaging of generic medicines in Brazil. In order to differentiate them from similars and reference (trade name) medicines, ANVISA establishes rules to identify them. The logo, consisting of a stylised 'G' and the words 'Medicament' and 'Generic' written in blue and enclosed in a yellow rectangle, must be displayed on the packaging, according to the 2001 ANVISA regulation [1].

One of the measures that have been introduced to promote the use of generic medicines in Brazil is the possibility of substitution of the brand-name medicine for its generic equivalent by pharmacists – interchangeability can occur at the time of purchase and at the request of the patient, except in cases where the prescriber requests, in writing, that the brand-name medicine is not to be replaced.

Another measure is the obligation for doctors in the public health system to prescribe medicines by their Brazilian Common Denomination (BCD) or, in its absence, by their international non-proprietary name. Mandatory reductions in the price of generic medicines compared to reference medicines have been seen as a way to boost their use – they must be registered at least 35% cheaper than their trade name equivalent, as established by ANVISA in its 2003 and 2007 regulations [1].

Since then, further rules on technical requirements for generic medicines have been published, see Table 1.

  
Editor’s comment
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Strategies for pricing of pharmaceuticals and generics in developing countries

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Reference
1. Nardi EP, Silva ARA. A closer look at generic drugs: the Brazilian case. In: Lowell T. Duncan (Ed). Advances in Health and Disease. Volume 21. Nova Science Publishers; 2020. Chapter 2. ISBN: 978-1-53617-783-1.

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