The impact of generics regulation in Brazil

Generics/Research | Posted 13/12/2019 post-comment0 Post your comment

Sales of originator drugs have decreased and the number of generics manufacturers have increased following the introduction of the Brazilian Generics Law, reports a new study [1].

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Access to medicines is a fundamental human right and should be equitable across the globe, yet access to essential treatments remains a significant problem in low- and middle-income countries.

In Brazil, the Unified Health System (SUS) provides medicines free of charge, provided they are on the national list of essential medicines. However, there is limited availability of drugs in the public sector. As a result, almost 30% of Brazilian households pay for private health insurance. At the same time, medicines in the private sector are expensive, making health care the fourth most important expense for households. This is particularly straining for the poorest in Brazilian society.

To tackle this problem, in 1999 the government approved the Generic Medicines Law and one year later the first generic medicines were approved in Brazil. A study recently published in the Journal of Pharmaceutical Policy and Practice [1] analysed the effect of this law on the Brazilian pharmaceutical market.

The researchers analysed data on sales by wholesalers to retail pharmacies between 1998 and 2010. Drug products were classified as originators, branded generics, or generics and covered three therapeutic classes (antibiotics, anti-diabetic drugs and anti-hypertensives).

The analysis found that, in the private market, generics became dominant in each therapeutic class. However, the speed at which this occurred varied. The transition to generics occurred most quickly for antibiotics, followed by anti-diabetics and last anti-hypertensives. The authors suggest this may be because antibiotics are used to treat acute rather than chronic illness.

Originator drugs consistently lost market share, while the market share of branded generics varied over time. By 2010, generics were the most sold product in all therapeutic classes, followed by branded generics. Concomitantly, the number of generics manufacturers increased.

Pricing varied by therapeutic class. Around half of the generic antibiotics analysed were cheaper than the originator and branded generics, although generic anti-diabetic prices were similar to the branded versions in the time period studied. Overall, prices for branded generics and originators decreased after the generics policy was introduced.

Overall, this analysis shows that the generics policy in Brazil has been successful in increasing generics market share. Following the introduction of the policy, sales of originator drugs and branded generics decreased and generics became dominant in all three therapeutic classes assessed in this study. The authors say future work should continue to assess changes in the market, which should be favourable for generics as consumer confidence grows.

Conflict of interest
The authors of the research paper [1] declared no competing interests.

Editor’s comment
Readers interested to learn more about the pharmaceutical market in Brazil are invited to visit to view the following manuscripts published in GaBI Journal:
Prescribing practices for biosimilars: questionnaire survey findings from physicians in Argentina, Brazil, Colombia and Mexico

First biosimilar of infliximab approved in Brazil: response from the Brazilian IBD society

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

1. Bertoldi AD, Wagner AK, Emmerick ICM, et al. The Brazilian private pharmaceutical market after the first ten years of the generics law. J Pharm Policy Pract. 2019;12:18.

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