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Conversation highlights:
- Current strategic context: implementing the new industrial policy (NIB) and placing health as a mission.
- Grupo FarmaBrasil maintains its tradition of presenting 4-year industrial policy proposals and has developed the vision Brasil Farma 2035: Industrial Framework.
- The Brazilian pharma industry's structural shift: from 1 Brazilian company in the top 10 by privatemarket ranking in 1998 to 5 today.
- Pillars enabling innovation: a strong, modern industrial base of locally owned companies, a more pro-innovation public framework, and regulatory & policy Advances
- Brazil is already the 8th-largest private pharma market globally and represents ~47% of Latin America, yet it still accounts for only about 2% of global production and consumption.
- Brazil’s size and socioeconomic reality mean it must expand access to generics and similar medicines, reduce API vulnerabilities (targeting the right “highpotency” segments), deepen innovation, and preserve universal access, all in parallel.
EF: What are the current priorities you're working on at Grupo FarmaBrasil?
RBA: Currently, we're deeply engaged with Brazil's new industrial policy, the NIB, where health was designated as the second priority mission. But FarmaBrasil has maintained a tradition since 2012 of preparing industrial policy suggestions every four years, presenting them to electoral candidates and established governments.
Last year, we produced Brasil Farma 2035, our strategic document that builds on the remarkable evolution of Brazil's pharmaceutical industry over the past 25 years. The transformation has a significant impact. In 1998, only one Brazilian company ranked among the top ten in the private pharmaceutical market. Today, five Brazilian companies are in the top ten. We believe this powerful, modern, and efficient industrial base positions us to leapfrog to a new standard of pharmaceutical manufacturing in the next decade.
Our main focus is simultaneously expanding the supply of generics to the Brazilian market while establishing a firm position in innovation. We have the conditions to support this dual approach. First, we have a very powerful industrial base. EuroFarma's new factory in Montes Claros, Minas Gerais, represents this perfectly; they've invested approximately $500 million in this greenfield plant. Biolab invested about half that amount in another facility. We can provide detailed investment data showing this trend across the sector. Second, Brazilian companies invest nearly two to three times more in research and development in Brazil than their foreign counterparts. This is understandable, as foreign companies tend to concentrate their innovation efforts near their headquarters and established R&D centers, primarily located in the northern hemisphere. In Brazil, the companies truly focused on innovation investment are Brazilian companies. EuroFarma exemplifies this approach, having allocated $100 million from its own budget to a venture capital fund that supports startups aligned with its portfolio priorities.
EF: What regulatory and policy developments are supporting this innovation roadmap?
RBA: After 10-15 years of efforts from our organization, we've achieved critical regulatory milestones that were decided and established on the government side. The most important was establishing new pricing control system standards that not only allow but actively foster innovation investment decisions.
The new rules provide clear pricing expectations for companies investing in products that can be formally characterized as innovative, value-added medicines, or radical innovation. This was issued in December last year.
Second, we finally have a law regulating clinical trials that was approved by Congress last year. The Ministry of Health issued the basic decree to regulate this at year-end, and we're waiting for ANVISA to approve a normative instruction next month that will detail the submission process for clinical trial projects and the rolling submission process.
Third, we have a huge and potent financing framework for innovation designed and operated by BNDES. Our companies have contracted nearly 4 billion reais, approximately $775 million, specifically for innovation projects. We're also successfully preserving Brazil's patent law against paradoxical attempts in Congress. One group wants to extend patents while another wants to break them, almost simultaneously. We're maintaining legal stability in the patent system, which is crucial for innovation investment.
EF: How does Brazil's approach compare to other developing countries pursuing pharmaceutical innovation?
RBA: There's a Brazilian economist who wrote about the 'Red Queen syndrome' from Alice's tale. Alice was always running, but the Red Queen was always ahead of her. The problem isn't just doing things and establishing what to do; you must cope with the speed of others. We know that besides developed countries, many developing nations are attempting similar transformations. We're stressing with the government that this kind of leapfrog process is possible in 10 years. India took 20-30 years, but China's data for the last decade is absolutely fantastic. If they can achieve this, so can we. This is the challenge we are putting forward to policymakers. The numbers seem contradictory, but are very interesting. According to IQVIA data, we're the 8th largest market globally for the private sector and represent 47% of the entire Latin American market. However, we represent only 2% of the global pharmaceutical market. This shows our expansion potential, which is why our companies are investing in huge facilities like EuroFarma's 250,000 square meter construction in Montes Claros. Brazil is an enormous market that we can expand many times over. But we must be a global player not just in quantities, but also in innovation. That's our challenge today.
EF: What opportunities do you see for Brazil to become a global pharmaceutical player by 2035?
RBA: I wouldn't be so bold as to say Brazil will be a global leader in pharmaceuticals; there's significant ground to cover for that. But we can certainly be a global player. Our most critical challenge is innovation, driven by permanent and alarming trade balance data. From 2024 to 2025, our trade deficit in medicines grew by 19%. We imported more than $14 billion in medicines alone in 2024, not including APIs, and these are the most sophisticated medicines: monoclonal antibodies and breakthrough therapies. Our companies are responding to this challenge. One of our member companies is now producing liraglutide, and we have 14 submissions to ANVISA for semaglutide biosimilars. This deficit shows we cannot continue with this dysfunction because it impacts our public system, which remains extraordinary by global standards. We're a country with a lot of needs, but we have a public system where you can access everything from headache treatment to heart transplants. We believe we're now at a different stage, truly able to move ahead faster than before.
EF: How does Brazil balance the need for self-sufficiency with becoming an innovation exporter?
RBA: For a country like Brazil, which spans a continent and has a population of approximately 213.4 million according to the Brazilian Institute of Geography and Statistics (IBGE), we need to simultaneously address wage and opportunity disparities while leveraging our strengths, such as having some of the world's best sustainable energy metrics. We cannot choose between priorities the way other countries might.
We must address our problems simultaneously: In pharmaceuticals, we need to continue producing more generics because many people need these medicines, and the public sector requires them. We must also address our significant API deficit, though we operate in an international system that allows access to good, cheap APIs from China, India, and Ireland. Interestingly, by value, we purchase more APIs from OECD countries than from India and China combined. The question becomes: what kind of APIs should we produce? Basic ones, or sophisticated high-powered APIs for cancer treatment?
We have companies producing and exporting sophisticated APIs to Europe. This convergence works because our companies are efficiently occupying the generics market and using those revenues to invest in innovation. We have a very good, large, and efficient industrial base controlled by Brazilian owners, and this is a key advantage.
The acquisition of Medley, the generic drug division of French pharmaceutical company Sanofi, by Brazilian company EMS in March this year, is yet another demonstration of the expansion capacity of the Brazilian pharmaceutical industry. Valued at around US$ 670 million, the deal represents the largest acquisition in EMS's history and strengthens the presence of Brazilian companies in a strategic segment of the drug market. EMS currently holds approximately 23% to 24% of the generic drug market in Brazil. With the acquisition, Medley's additional share, estimated at between 7% and 8%, brings the combined share to approximately 30% to 31%, consolidating the company's leadership in the segment. The move shows how the Brazilian pharmaceutical industry has the capacity not only to compete, but also to lead investment processes.
