Report from Brazil May 2013

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.
May 02, 2013
Volume 37, Issue 5

Brazil's regulatory chamber of pharmaceutical products market (Anvisa-CMED) has authorized pharmaceutical products in the country to have prices adjusted by up to 6.31% starting on March 31, 2013, according to Anvisa, an agency that monitors drug prices and gives technical support for the definition of drug prices. One of the agency's attributions is the Executive Secretariat of the Drug Market Regulation Chamber (CMED), which is an interministerial body responsible for drug market regulation and for establishing criteria of drug prices definition and their adjustments.

Anvisa, led by the Ministry of Health, has set percentages for raising the price of antibiotics, anti-inflammatory agents, diuretics, and other drugs. Homeopathic and naturopathic products are not subject to such price increase. The cap-price determined will be frozen either for a one-year period or until March 2014. According to the Brazilian Pharmaceutical Wholesalers Association (Abafarma), the percentages vary between 2.70%, 4.59%, and 6.31%, and were stipulated based on the market share of each product in the local market in comparison with generic brands of the same drug. As Abafarma executives note, the only products in Brazil to have price controls are pharmaceutical drugs.

Price-cap regulation

Since 2003, Anvisa's regulatory chamber has managed price controls of pharmaceutical drugs commercialized in Brazil by setting price-cap standards. The "production" price-cap defines the maximum wholesale price at which a pharmaceutical drug may be sold in the Brazilian market, while the "consumer" price-cap is the maximum price at which it can be sold to the customer at drugstores and pharmacies around the country.

The regulatory authority defines the maximum price of pharmaceutical drugs through CMED's Resolution 2/2004. New drugs entering the market will be put in categories and priced according to their use and scientific evidence according to the regulatory authority. When considering the price-cap for new pharmaceutical products, the local authority will also evaluate the lowest international price for that product using certain countries as a parameter, including the country where the drug was produced, as well others such as the United States, Canada, Spain, Italy, Portugal, Greece, France, Australia, and New Zealand.

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