Many of the biggest current producers do so in generics, and Odnir Finotti, executive president of Pró Genéricos, sheds a
light on why this might be. "For the time being, 90% of the Brazilian [retail] market is out-of-pocket, therefore all these
people need to have access to affordable and trustworthy medicines, and this is what generics is all about. Today, many more
Brazilians have access to pharmaceuticals, so people are taking better care of health than ever before thanks to generics,"
he says. Furthermore, Finotti explains the rationale for domestic firms targeted as acquisitions from international players:
"It's about market size and upside potential. We're talking about the seventh-largest market in the world, and increasing.
According to the latest data from IMS, by 2015, Brazil will be No. 3 in generics. It is a quite strong reason to acquire a
generics company in Brazil. If you do not produce here, or control the columns that keep generics standing, you are not in
the game. Brazilian companies learned very quickly how to play in generics. We can compete worldwide on the same base in cost
of development and formulations, etc. In this, Brazil has the expertise. Some of the largest companies in Generics are not
present in Brazil yet, for they cannot simply bring its entire portfolio from elsewhere. You need to be here—plant here, manufacturing,
developing formulations, etc., here."
Case in point: Sanofi. With the Brazilian operations boasting the largest production outside the company's historical French
borders, Heraldo Marchezini, senior vice president for Latin America and general manager Brazil global operations, can boast
of steering the crown jewel of the company's emerging market portfolio. However, Sanofi is not merely a fair-weather friend.
Speaking to the importance of long-term commitment, and actually being Brazilian, Marchezini says, "There is an understanding
one achieves from knowing where a country has been, and how we've gotten to where we are today. This is especially important
in the pharma market, because there has been a tremendous transformation in recent years in the way it operates. If you would
have come in the 1990s, you would have found many companies that had left Brazil due to a tough economic situation, and a
complete lack of patents. (And, as an aside, this is why I don't complain about ANVISA, having seen what we had in the past!)
Underlying all these changes is a significant process you have to understand: the generics law, which was put in place in
2000; the patent law in 1996 when Brazil entered the WTO; and the Real Plan in 1993. These are elements that it's possible
to understand unconsciously, if you are Brazilian, about how the health is understood by policymakers, agencies, and the population.
It's interesting, because perhaps only in answering this question do you realize how important it is!"
Other than the local touch, Marchezini highlights the company's adaptability to many different markets as a key success factor.
"We have a really diversified approach, which spans from generics, to OTC, consumer goods, prescription, mature products,
vaccines, Genzyme—the company goes from the basic to the very high tech, to oncology, and everything in between. The reality
is that you have to adapt to local needs. Brazil has a demand for everything; it's a matter of how you manage this. There's
much more volume, and our industrial presence is significant, because we have medicines that really fit into the vast majority
of the population's needs," he concludes.
Dirceu Barbano is the director president of ANVISA, and in 2011, he was re-elected to a second, and final, three-year term,
and will remain director until 2014. In this time frame, will he be able to shed the regulatory body's reputation, which naysayers
lament as lacking speed? "We're speaking of two types of performance here," he quips. "One is related to quality and rigor
in our regulatory actions. The other is about efficiency. ANVISA can accept that the performance of rigor interferes with
the efficiency, but not the other way around. ANVISA counts over 2,000 workers who seek to preserve rigor while enhancing
efficiency. There are cases that indicate a way to make these two performances closer. This involves an improvement in norms,
and searching for a focus on health risks," says Barbano, former director of the committee that introduced Farmácia Popular.
He elucidates the public stance: "We have a very clear orientation from the government, and it is one you will hear from the
Ministry of Health: Every time there is a question of whether to put public- or private-sector interests first, we don't hesitate
for even half a second to opt for the public interest."
Giles Platford, general manager, Nycomed Brazil
With noble talk like that, companies are bound to be slightly frightened. And the reputation of ANVISA as a red-tape-ridden
bureaucracy is legend. But it depends who you ask. Martin Nelzow, president of Boehringer Ingelheim Brazil, the country's
fastest-growing MNC, is unambiguous. "I cannot blame the government at all for delaying registration; the opposite is true,
in fact." According to Nelzow, Boehringer Ingelheim has received all its registrations before schedule. "It's time to forget
certain past prejudices. Of course, one can always choose to submit the dossier, wait, and blame—but Boehringer Ingelheim
prefers to be more creative."
Devaney Baccarin, vp and general manager, Astellas
Nelzow elaborates on a special case study: "We have had two very interesting situations of submitting a truly innovative drug,
where Brazil would be the second or third market in the world with this particular compound. We approached ANVISA and suggested,
Why not organize a panel? Call all the people you believe should have questions or issues, and we will also ask the people
from the medical societies, our researchers, and technicians. We put all these people in one room for a one-day discussion
and it was done. In terms of innovation I cannot say that ANVISA is delaying, and our relation with them has been absolutely
And clearly ANVISA has not stunted Boehringer Ingelheim's growth, posting year-over-year figures of 14% in 2011, and boasting
household brands such as Buscopan and Anador in the top-selling therapeutic classes of analgesics, and Micardis, an antihypertensive,
also a No. 1 brand in growth in 2011.
Rubens Lima, general manager of Ipsen Pharma Brazil, takes a different tack. "It's important for Brazil to attract international
investments, to better evaluate the impact of administrative burden and approval timelines, and align these standards to international
benchmarks," he says. "It's a myth that there's an inverse correlation between rigor and efficiency—the two are not linked.
Look at the FDA: very rigourous, yet with much faster timelines, while ANVISA and MoH processes, even rigorous, are by far
longer and lead to significant delays in product launches."
Roberto Alvarenga, general manager of Ferring Pharmaceuticals Brazil, weighs in nicely, noting, "I think the industry needs
to be fair with the government. There are some mistakes from pharmaceutical companies. Sometimes the quality of the dossiers
submitted is not good enough. We need to be fair here; often the industry fails in this basic regard. Companies need to, at
minimum, prepare good enough dossiers to approve, although this is only a concern for some companies." However, he puts a
qualifier on his kindness, and stresses that, "yet another issue is I don't believe the government has the right size, in
terms of numbers and quality of staff, to evaluate all the submissions."