Report from Brazil - Pharmaceutical Technology

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Report from Brazil
Prior to price escalation of pharmaceutical products in Brazil, the country's regulatory authority released a study on price-cap control and its benefits in the past years.

Pharmaceutical Technology
Volume 37, Issue 5, pp. 34, 68

Control benefits

The study, released in January 2013 by Anvisa, analyzed pricing standards in the past years and concluded that the current pricing regulation has enabled Brazilians to purchase pharmaceutical drugs at prices that are on average 35% lower than the values initially requested by the pharmaceutical industry. The study analyzed cap-prices established by CMED between March 2004 and December 2011 for 1115 formulae/presentations and 433 pharmaceutical drugs.

According to the management of Anvisa, the prices of pharmaceutical drugs entering the Brazilian market ended up lower than those presented to Anvisa by pharmaceutical companies because of the established price-cap market regulation, which impeded companies from charging higher values. The study evaluated the prices of pharmaceutical products containing new molecules, drugs to be sold in new pharmaceutical forms, and new associations for known active ingredients. The study showed that new associations of active

ingredients already existing in the country and drugs in new pharmaceutical forms (category V) had a difference of 38% between the final price and the price requested by the industry. Other pharmaceutical products that could not be included in any category established by the government had their prices "reduced" by an average of 35% and 45%.

For products carrying innovative molecules patented in Brazil and those that have been proven to offer therapeutic benefits compared with drugs already being applied for the same use (category I), the study showed that the final cap-price was on average 19% lower than the value requested by the pharmaceutical industry, Anvisa stated. Other new products that were not patented in the country, or that had not been proven to offer therapeutic benefits (category II), had a reduction of 37% on average compared with the original price suggested.

Study details

Of all the pharmaceutical drugs studied, 45.03% were category II products. New associations of active ingredients already existing in the country and drugs in new pharmaceutical forms (category V) made up 36.72% of all products analyzed. Drugs carrying innovative molecules patented in Brazil and that have been proven to offer therapeutic benefits compared with drugs already being applied for the same use totaled to only 3.24% of all drugs studied. The other "unclassified" categories totaled to 15.01%, according to Anvisa. A relevant aspect of the study was on the number of foreign companies and Brazilian firms that were granted pharmaceutical authorizations by Anvisa for drugs carrying new molecules. According to data from the study, foreign capital firms represented nearly 82% of the total number of companies that had authorizations issued under categories I or II. However, the study showed that there were no domestic companies offering pharmaceutical drugs under category I.

Anvisa's original study is available at

Hellen Berger is a business writer based in São Paulo, Brazil.


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