Minister Pimentel recently released the BrasilMaior plan, whose slogan is “Innovate to compete. Compete to grow.” How would you recommend the government innovate, compete, and grow in the pharmaceutical industry here in Brazil?

First of all, the government must keep the status quo to respect intellectual property. This is imperative, because in fact, it’s a very thin line and very important for pharmaceutical companies. When a crisis occurs between the government and a specific company, there is often a subtle threat implied to other companies around breaking patent protection. This should be a non-negotiable issue.
Secondly, and this has been discussed in some specific areas of the BrazilMaior plan, is to decrease taxes around employment and medication.
The third is to bring Brazil up in the research world. To best compete, we need to include Brazil in clinical studies, and often, we waste time in a lengthy approvals process. I don’t know the exact reason why, but the fact remains that if we want to bring Brazil up in the global scenario, we need to improve the speed of clinical trials.

Regarding your first point, hasn’t the Brazilian government has only broken patent once, on the AIDS drug Efavirenz, in 2005?

That it has only been one time is not an excuse. “Never” is the right answer! When it’s done once, it creates a precedent for the future.

When we met with ANVISA, Mr. Barbano said if he has to choose between the health of our people and the health of our corporations, we don’t take half a second to choose for our people.

I absolutely agree! I have been working for pharmaceutical companies for 30 years. Comparing ANVISA of 10 years ago to today, you clearly see a huge progress. For example: Today the time frame to approve one product, if you give a robust dossier, is one year. I don’t think that’s unreasonable. The issue is that sometimes, it’s not the process that’s wrong. Sometimes there are people in the middle of the process who don’t follow the process. But I am very optimistic for a continual improvement.

Venvanse’s recent launch is obviously the most exciting development on the Specialty Pharmaceuticals side, but Shire itself is new to Latin America in this part of the business. How has the company’s entrance fared thus far?

Around the world, Shire is composed of two entities: HGT (Human Genetic Therapies) and Specialty Pharmaceuticals. In Latin America, Shire is in the reverse competitive position compared to the rest of the world: HGT is already well-established, operating for over four years, whereas the Specialty Pharmaceuticals franchise arrived in Latin America just one year ago – actually, I was the number one employee for Latin America! Shire’s Leadership Team realized that it’s better to have a local presence than to implement the portfolio via partners. Since the decision was made to establish an office in Brazil, the first product launched was Venvanse, in May, 2011, and it is doing really well.
In the Brazilian ADHD market, the gold standard treatment is methylphenidate. Shire faces a strong competitive landscape with two methylphenidate products in the market, Ritalin and Concerta. Shire is bringing a new, longer-lasting option, with a different profile and many benefits.
I’m not saying we’re here to displace methylphenidate – Venvanse is a new generation for the ADHD treatment and will be prescribed based on doctor’s judgement depending on the patient profile.

It’s estimated that 10 million Brazilians suffer from ADHD, and only 100-150,000 are being treated. It seems like a huge potential. Where’s the disconnection?

The treatment rate is very low in Brazil. It’s a relatively new disease, and awareness is low among stakeholders. Therefore it is our role to educate everyone involved around the disorder. On the other hand, it’s important to note that ADHD treatment has been growing at 30% average annually, compared to 12% growth in the pharmaceutical market overall. This is somewhat due to an increasing trend of parents becoming more comfortable bringing their children to doctors for ADHD treatment.

That’s an interesting point. What’s the perception of a disease like ADHD in Brazil? In North America, there’s a certain backlash, with Ritalin almost a catchphrase for overprescription, and many advocates of simple diet, exercise, and proper parenting.

Every time you bring attention to a new physiological disorder, many people try to deny its existence. At the end of the day, it comes down to a simple question: would you like to help your child, or not? If you want to help your child, you must accept that a problem exists and that there’s a potential solution. It’s a matter of choice.

What’s the importance of Brazil in the overall Shire Specialty Pharmaceuticals portfolio?

At present not much, because we just launched our first product. However, Brazil is a “pharmemerging market”, to use the term coined by IMS. Within five years, we expect Brazil to become the third or fourth market for Shire, and a top 5 ADHD market.

What’s at the top of your priority list?

The big challenge is to establish Shire in Latin America. Starting with Brazil and Mexico, which represent 65% of the Latin America market. However, even smaller countries have big potential – Argentina, Venezuela, Colombia, etc. The challenge is how to operate in big and small countries alike – the work, vision, and establishing a strategy is a big challenge. I have to make a decision how to operate in Latin America outside Brazil and Mexico, and how to build this structure is my most challenging task.

What is that vision for the future? If we came back in five to 10 years, what would we see?

Shire wants to be present in those very specific niche markets that don’t need a huge sales force. By the way, this is the future of pharmaceutical companies: we’re going to have big companies operating with generics, and niche companies operating in very small markets. This is a typical path. Look at Pfizer’s, which bought Teuto – volume, low price – and Wyeth, which produces vaccines and very specific, niche market products. Sanofi-Aventis is the same, with their acquisition of Medley. That’s the way the pharmaceutical companies will be. You can forget the huge military sales forces for a Lipitor or Viagra – that era is over.

You mention not taking over Concerta or Ritalin, but you were responsible for introducing Cialis in Brazil, one of the most successful launches in the country’s history.

Do not get me wrong. We want to be in the first place, of course. If you compare Venvanse to Cialis, it’s the same situation: it’s an outstanding product. You cannot compare Venvanse with existing products in the market, period. Each patient has its different needs and we are here to get our share of this market. In the same way that patients still prefer Viagra over Cialis, some patients will prefer another product to Venvanse as well.

Your career spans over 30 years among many companies, in Brazil and abroad – what drives you today?

My motivation today links with my key challenge at Shire – how to put Latin America in Shire’s Radar. When I wake up every day, that’s my goal.
Many executives complain about checking Smartphones at work a lot, emails on the weekend and holidays. What I say to executives is, if you don’t like it; open a funeral home, because your customers will never complain!