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.
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 http://s.anvisa.gov.br/wps/s/r/b3ZE.
— Hellen Berger is a business writer based in São Paulo, Brazil.