Abstract
In terms of emerging pharmaceutical markets, Brazil remains one of the most
attractive to multinational
pharmaceutical companies operating in the
Americas. BMI’s Business Environment Rankings for Q309
places the
country fifth among the 10 countries covered in this region, with Mexico the
only ‘emerging’
market ahead of Brazil. The strength behind
this score is the country’s dynamic growth, which BMI
forecasts will
expand at a compound annual growth rate (CAGR) of 11.2% in US dollar terms
through to
2013.
In addition to the country’s dynamic growth,
overall market size remains large – although eclipsed by the
US
– with per capita spending up by nearly 130% since 2004. Meanwhile, an
increasingly urbanised
population and steady growth provide opportunities,
despite the country’s relative young age profile. The
country’s regulatory body, which has been criticised in the past, is
becoming increasingly proficient in
terms of allowing access to
pharmaceuticals; however, intellectual property (IP) concerns prevail.
Meanwhile country risk scores remain competitive with other Latin American
countries.
Regarding intellectual property, Brazil remains on the
Pharmaceutical Research and Manufacturers of
America (PhRMA)’s
‘Priority Watch List’ due to its patent application backlog, the
use of originator data
to approve competitor products and the absence of
any link between the patent system and procedures for
approving the
marketing of pharmaceutical products, including generic products.
In 2009
Brazil’s National Health Surveillance Agency (ANVISA) has taken initial
steps to upgrade Good
Manufacturing Practice (GMP) standards for medicinal
products, by introducing a new proposal for
public consultation. The
review of standards stems from recommendations from the World Health
Organization (WHO). Marília Cunham, general manger of ANVISA’s
inspection division, said that the
goal of the proposal is to monitor the
development of new technologies in recent years and the importance
of
national and international documents on the subject.
Meanwhile regulator
CMED has authorised a maximum 5.9% increase in the price of medicines for
12
months commencing through to March 31 2010, affecting 17,950 product
presentations. The increase
equals the expanded consumer price index
(ICPA) percentage rise in 2008 (and between March 2008 and
February 2009),
as calculated by the Brazilian Institute of Geography & Statistics (IBGE).
The Brazilian Pharmaceutical Industry Federation (Febrafarma) has once again
pointed to reduced sales
taxes, rather than price controls, as a key
mechanism for reducing costs to patients. Taxes account for
33.8% of total
medicine costs in Brazil, significantly higher than many other essential
goods.
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