According to the National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria, ANVISA), the approval of medicines aims to improve the Brazilian population's access to better, safe and quality medicines at lower prices.
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.
| Table 1: Main laws, regulations and decrees on generic medicines in Brazil 1999–2019
|
| Year
|
Law/Regulation
|
Content of the Law/Regulation
|
| 1996
|
Law No. 9279 of 14 May 1996
|
Intellectual Property Rights Act
|
| 1998
|
Ordinance No. 3916 of October 1998
|
Guiding instrument for all medicines-related actions in the country
|
| 1999
|
Law No. 9787 of February 1999
|
Law on generics - generic medicines legally established in Brazil
|
| 1999
|
Decree No. 3181 of 1999
|
Regulation of Law 9787
|
| 2001
|
Resolution RDC No. 47 of 2001
|
Identification/packaging of generic medicines
|
| 2007
|
Resolution RDC No. 53 of 2007
|
Dispensing medicines
|
| 2015
|
Law No.13235 of 2015
|
Quality of similar medicines
|
| Source: ANVISA.
|
Editor’s comment
Readers interested to learn more about pricing of generics are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Strategies for pricing of pharmaceuticals and generics in developing countries
GaBI Journal is indexed in Embase, Scopus, Emerging Sources Citation Index and more.
Readers interested in contributing a research or perspective paper in Spanish and/or English on substitution and prescription to GaBI Journal – an independent, peer reviewed academic journal – please submit your manuscript here.
GaBI Journal Citation Impact
1.9 – CiteScore 2020 (calculated on 5 May 2021)
1.6 – CiteScoreTracker 2021 (Last updated on 4 June 2021)
Submit a manuscript to GaBI Journal
Related articles
The generics market in Brazil
Legal requirements on equivalence studies for generics in Brazil
Backlog of drug patents in Brazil
| LATIN AMERICAN FORUM The brand-new section the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View this week’s headline article: Biosimilares en Japón: una perspectiva general Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de esta semana: Biosimilares en Japón: una perspectiva general Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.
|
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.
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2021 Pro Pharma Communications International. All Rights Reserved.
0
Post your comment