At its recent assembly in Bogotá, ALIFAR – the Latin American Association of National Pharmaceutical Industries – brought together chambers from 14 countries to set a shared agenda for 2025. Representing hundreds of laboratories and thousands of workers, ALIFAR is working to strengthen the region’s pharmaceutical base through sovereignty, innovation, and patient access. In this interview, Ruben Abete, Executive Secretary of ALIFAR, reflects on the lessons of the pandemic, the need for regional production, and the opportunities for Latin America to consolidate its role in the global pharmaceutical landscape.
ALIFAR recently met in Bogotá to discuss how to strengthen the regional pharmaceutical base. What are the association’s main projects for 2025, and how do they align with the common agenda of sovereignty, innovation, and patient access?
Our annual meeting is the space where we define the industry’s priorities for the region. ALIFAR brings together the chambers of national pharmaceutical producers in 14 countries, representing hundreds of laboratories and thousands of employees. This level of representation obliges us to consider not only the interests of each individual market but also the need for a shared regional agenda.
We work closely with regulators and international organisations such as PAHO and WHO. Our strategy is simple: maintain a common agenda to address shared challenges professionally, while also recognising and responding to the specificities of each country. This combination of regional vision and local action is crucial to establishing a stronger pharmaceutical foundation.
What are ALIFAR’s top priorities today?
The pandemic was a turning point. It revealed that the global health system, despite years of planning, was not prepared. The response was fragmented – each country acted as it could – and mechanisms such as emergency licenses for intellectual property did not work in practice. Patents were not released, there was no meaningful technology transfer, and privileges remained in place, which only deepened inequities.
From this experience arises our central priority: ensuring that Latin America has its own production capacity and does not depend exclusively on external decisions. That is the essence of health sovereignty.
How did you come to lead ALIFAR?
Almost by chance. After completing my residency as a surgeon, a taxi driver mentioned to me the construction of a new naval hospital in Buenos Aires. That led me to join the Navy, later to participate in the war with the United Kingdom, and eventually to enter the pharmaceutical industry due to family circumstances.
Over time, I trained in management, marketing, and business administration, eventually becoming president of CILFA in Argentina for nine years. Today, I continue to serve on the board and chair its ethics committee. In this way – quite unexpectedly – I found my path to ALIFAR.
Regarding intellectual property, what is ALIFAR’s position in the context of local innovation and development?
We defend intellectual property rights, but not as absolute monopolies. A balance must be struck: innovation must be protected, yes, but medicines must also reach the population. High-cost biologics are a clear example – they are major scientific advances, but without competition, they remain out of reach for most people.
It is well proven that responsible competition improves access and reduces prices. An organised, fair competition benefits both patients and health systems.
ALIFAR brings together chambers from 14 countries with very different realities. How do you balance this diversity while promoting a unified vision?
What unites us is the principle of national capital and national production. Beyond the fact that we compete in our markets, there are values we all share: the national industry is strategic for each country. During the pandemic, those countries with local production were able to cushion the impact of shortages, while those entirely dependent on imports faced much greater difficulties.
That is why we build on common ground, regardless of commercial or regulatory differences.
The Latin American pharmaceutical market exceeds USD 100 billion in size, yet it remains highly dependent on imports and faces regulatory fragmentation and unequal access. What are the most urgent structural challenges?
The export bans imposed by India and China at the end of 2019 were a wake-up call. Overnight, APIs became scarce, and with them even the most basic medicines. I remember there were no muscle relaxants available to intubate patients in intensive care. These were not cutting-edge biotechnologies, but old, low-cost medicines – and without them, patients’ lives were at risk.
This episode showed how dangerous it was to have moved almost all API production to Asia. It was a decision based on low labour and environmental costs, but it left the rest of the world vulnerable. Today, we insist on bringing part of that production back to the region.
Currently, about 80% of APIs are imported. What steps is ALIFAR taking to reduce this dependency and move toward greater health sovereignty?
We are working with governments and with PAHO to define a regional strategy. The idea is not for each country to set up dozens of plants; rather, we must think in terms of a shared production network that guarantees the essentials. The pandemic made it very clear that depending on Asia is unsustainable. The key is to coordinate regional priorities and make collective decisions about what should be produced locally.
Despite these challenges, we see progress in biosimilars and biotechnology. Where do you see the biggest opportunities for Latin America to strengthen its role in the global pharmaceutical value chain?
There are already concrete results in biosimilars in Argentina, Brazil, Mexico, and Colombia. This is no coincidence: the region has a solid scientific base – just recall that monoclonal antibodies were discovered by an Argentine Nobel laureate – and a growing technological capacity.
When high-quality biosimilars reach the market, the impact is immediate: the price of the original product can drop by as much as 50%. That translates into billions of dollars in savings and expanded access. The opportunity lies in consolidating these biotech hubs and continuing to invest in advanced manufacturing.
China and India are global benchmarks in pharmaceutical production. Why has Latin America not reached that scale?
Brazil is an interesting case: its domestic consumption is so large that most of its production stays within its borders. By contrast, China made a deliberate decision decades ago to transform its economy. It went from being a closed system to becoming a technological powerhouse, with a national plan to train engineers and technical specialists.
I recall a meeting with the China Industrial Union, where I was designated by WIPO to participate. Every Chinese representative around the table was an engineer with a specialised master’s degree. I was the only physician there. That strategy of prioritising technical training explains much of their leap forward. Latin America has not yet achieved that level of long-term planning.
In Europe, the EMA has achieved regulatory convergence. How feasible is something similar in Latin America?
It is both feasible and necessary, but it requires a cultural change. Regulatory agencies should not be seen as barriers, but as strategic partners of the industry. They exist because there is private production to regulate. We need strong, well-trained, and collaborative agencies that facilitate development and raise industry standards.
Progress is already evident: 20 years ago, many small and medium-sized companies in the region lacked both knowledge and equipment. Today, those same firms are handling cutting-edge technology. Regulation must keep pace with that progress, not hold it back.
Since the pandemic, we have seen more public-private collaboration. How do you evaluate this process?
It became clear that regulators and industry must work together. Policies cannot be designed in isolation without the input of those who will implement them. To build resilience, we need long-term state policies on health and medicines, not short-term government measures.
The LatAm region invests less than one percent of GDP in R&D. What is needed to attract more investment in biotechnology, biosimilars, and advanced manufacturing?
Our biggest obstacle is instability. Policies shift with every government change, and that discourages investment. What we need are public policies with a 20- or 30-year horizon, policies that remain in place regardless of who is in power. Only that kind of continuity can guarantee stability and sustained growth.
Looking ahead, how do you see the role of digitalisation, traceability, and logistics innovations in the coming decade?
They will be decisive. A historical example: in the 1970s, the arrival of personal computers allowed researchers to design molecules on screen, which gave rise to drugs such as cimetidine. That innovation completely transformed medicine, eliminating the need for countless stomach surgeries.
Today, digitalisation is already enabling full traceability, electronic prescriptions, and more efficient logistics. This will change not only how medicines are produced, but also how they are distributed and accessed.
What would be your final message to our global readers about the Latin American pharmaceutical industry?
Knowledge is the heritage of humanity and must be shared. If we monopolise it and turn it into money, we may build a profitable business, but I do not believe the outcomes would be positive. We must strike a balance between technological advances, intellectual property rights, access to medicines, and technology transfer. Regulatory agencies, governments, and multinational organisations must work together within a harmonious, consensus-driven ecosystem. The mindset should be at least regional before it is global.
