AIDSWEEKLY Plus; Monday, April 30, 2007
Staff Medical Writers

A number of products are due to lose their patent protection between 2007 and 2012, bringing market opportunities worth US$307.2 million to the generics sector. Key products affected include Plavix in 2007, Mercilon in 2009 and Viagra and Lipitor, both in 2011. At manufacturers' prices, their respective sales stood at US$41.1 million, US$58.3 million, US$73.1 million and US$53.4 million in 2005.

Furthermore, in March 2007, ANVISA authorised the registration of generic alternatives to oral contraceptives and endogenous hormones. This sector was valued at US$481 million in 2006 and generic producers are expected to account for 60% by 2012. The leading producers, including Medley, EMS-Sigma Pharma and Eurofarma, have indicated that they will enter this market.

Meeting the challenge of AIDS

Since 1996, antiretrovirals have been provided free of charge to HIV/AIDS patients. The cost per patient fell from R$8,500 (US$4,574) in 1999 to R$3,400 (US$1,162) in 2004, but rose to US$2,500 in 2005. Costs remain high as imported antiretrovirals represent between 80% and 85% of the national AIDS programme's expenditure. According to the Ministry of Health, public domestic manufacturers produce eight of the 17 antiretrovirals used.

Brazil can issue compulsory licences and allow local generic production of imported antiretrovirals. So far, it has negotiated drug price reductions and encouraged local production under licence. However, the rising number of patients, increasing levels of drug resistance, rising costs, the lack of systematic surveillance of HIV prevalence and high-risk behaviour might still be a threat.

Domestic producers dominate...for now?

There were 66 producers with registrations of generic medicines in 2006, but the four leading producers, which are indigenous, controlled over 80% of the sector. Medley and EMS were the leaders, with a combined 65% market share, followed by Eurofarma and Ache. Mergers & acquisitions will continue to consolidate the Brazilian generics market.

Local producers dominate with low prices and increasing production capabilities. They also have the local know-how to deal with bureaucracy and the government favours them. With the global generics markets consolidating into ever bigger groups, markets such as Brazil are increasingly under scrutiny from large generic corporates. All - with the exception of Teva - have some presence or alliance in Brazil, but it is probably only a question of time before the domination of the market by local companies changes.

Keywords: HIV/AIDS, AIDS, Acquired Immunodeficiency Syndrome, Antivirals, Business, HIV, Human Immunodeficiency Virus, Patents, Virology, Research and Markets Ltd.

This article was prepared by AIDS Weekly editors from staff and other reports.

2007-04-30
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