vre its rates and the need to protect the domestic market
from indiscriminate entry of foreign products.”
2) On March 13, 2013, a tax deferral measure was officially published to suspend goods circulation taxes in the state of São
Paulo for domestic products and imported pharmaceutical
ingredients or intermediate drug products purchased by the
Foundation of Popular Medicines (Fundação para o Remédio
Popular). The Foundation is linked to the Department of
Health of the state of São Paulo and is responsible for developing, producing and distributing pharmaceutical products
in Brazil. This rule is valid for imported generic or biosimilars not yet available in the country.
SEEKING NEW PARTNERSHIPS
Brazil recognizes that the development of technology in
healthcare is necessary to strengthen national industrial manufacturing, reduce dependency on product importations and
achieve better control over expenditure.
To date, 34 technology transfer partnerships between public and private laboratories have been agreed upon for the
production of 28 drugs (including Pramipexole, Tenofovir,
Clozapine, Quetiapine, Olanzapine, Tacrolimus, Rivastigmine,
and Donepezil), and three vaccines. According to the Ministry
of Health, at least 20 new partnerships are expected over the
next four years, including biological products and medical
For instance, in October 2012, Boehringer-Ingelheim and
the Institute of Drug Technology (Farmanguinhos) agreed
on a partnership for the local production of Pramipexole for
Parkinson’s disease treatment. Boehringer-Ingelheim will supply the active ingredient that Farmanguinhos will convert into
tablets. The expectation is to produce internally 50 percent of
the country’s demand by 2016 and 100 percent by 20181.
In the medium- and long-term, stakeholders are not only
seeking internal development, but they are also hoping to
increase competitiveness of Brazilian pharma companies
abroad. A further step in this direction was made earlier
this year when Brazil’s President Dilma Rousseff announced
that the recently created Brazilian Enterprise for Research
and Industrial Innovation (Embrapii) will be responsible for
promoting partnerships between public innovative research
institutions and private companies to create new products
INCREASING GENERICS MARKET SHARE
Generics were introduced in Brazil 30 years ago, and met
with general consumer and prescriber distrust. Today, gener-
ics market share in Brazil is still lower than in other markets,
e.g. 26 percent in 2012 compared to 66 percent in Germany,
and 60 percent in the UK and US, but it is expected to in-
crease to 45 percent by 2020. According to the Pro-Generics
association, by the end of 2013 the market share of generic
drugs should increase to 30 percent.
The Brazilian government is aggressively promoting the
use of generics and seeking to further increase confidence in
patients and prescribers by ensuring rigid quality controls
and lower prices. With a price at least 35 percent cheaper
than brand-name drugs, and with several Brazilian companies
operating in the sector, generic manufacturing was identified
as an ideal way to increase budget control and boost local
WHAT DOES THIS MEAN FOR YOUR COMPANY?
In the coming years, the favorable healthcare environment
will allow local companies and generic drug makers to rapidly
increase their market share and negatively impact on international manufacturers of branded products. Moreover, key
decision-makers are expected to adopt stricter regulatory,
pricing and reimbursement regulations to further develop internal pharmaceutical manufacturing.
As a direct consequence, market access in Brazil will be-
come increasingly challenging for international pharmaceuti-
cal companies, making it necessary for global businesses to
evaluate and adapt their business strategy to local realities.
Strategic offerings, including technology transfer agreements, will be a key factor to secure continued market sales
growth in the next few years. International pharmaceutical
companies should also consider financial/outcome-based
pricing agreements and other alternative approaches to meet
the increasing demand for access to healthcare without impacting excessively on budget.
Keeping track of legislative, pricing and reimbursement
changes, foreseeing how competitors’ launches will impact
your portfolio, and linking Brazil to global decisions and international referencing pricing are essential for identifying
and bending gaps and trends that shape the pharmaceutical
market in your favor.
1 http://www.brazilpharmanews.com; Accessed 19th April
2 ANVISA and brazilpharmanews; Accessed 19th April 2013 ■
PHARMACEUTICAL PROCESSING | OCTOBER 2013 21 ■
Despite its strong economic growth, Brazil is facing increasing pressure to
control healthcare expenditure and, at the same time, to promote innovation
and improve access to healthcare.