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EF: What is your mission as the new President of PróGenéricos in Brazil, and what are the key priorities on this year's agenda?
TM: One of my missions at the head of the organization is to make PróGenéricos the main point of collaboration and meeting point for the generic and biosimilar drug industry with the Government, our regulation organization Anvisa, the National Institute of Intellectual Property, and other strategic stakeholders.
After more than 20 years working in Brasília, most of my career in the private sector and with the task of working closely with the public sector, I understand that the basis of my work at PróGenéricos will be intense cooperation and alignment between the two sides in the best interests of the public and private sectors.
I intend to continue and improve PróGenéricos' actions, which have been carried out for more than two decades to guarantee access to health through generic and biosimilar medicines. The aim is to strengthen these markets, assuring even greater access to safe, quality medicines at a price of at least 35% lower.
The Brazilian market is very advanced, and we want it to go even further. At this very moment, Brazil is discussing policies to modernize the national industry, and our sector can - and should - make a significant contribution based on technological and innovative advances that will guarantee more protection for the population's health in a shorter time.
EF: How does the Generic Pharmaceutical Market impact the Brazilian economy and society?
TM: Starting with Law No. 9.787, Brazil’s generic drug program has impacted society and the economy since 1999.
Over the last 24 years, generics have established themselves as an important tool for cheaper treatments, ensuring greater access to the population. As well as being more affordable from a financial point of view, generics in Brazil have proven safety and efficacy, guaranteed by the National Health Surveillance Agency (ANVISA). These characteristics allow us to continue on this important mission to promote health for all and contribute at a lower cost to the Unified Health System (SUS).
Brazilian legislation stipulates that generics cost 35% less than reference products. However, in practice, the price difference can reach 60% due to the wide range of products and manufacturers on offer, which makes the generics segment very competitive, a scenario that benefits the industry and, above all, patients
Of the 20 drugs most prescribed by Brazilian doctors, 15 are generics, demonstrating the confidence in this category’s quality, efficacy, and safety. We represent more than 36% of retail sales. These figures are significant, but there is room for more. Our mission is to increase market share, ensuring more and more people have access to generic medicines.
EF: What are PróGenéricos main priorities for 2023-2024?
TM: My career has been in the area of institutional relations. Therefore, I understand and work to strengthen agendas with the axes of public power, and the regulatory agencies. They play a fundamental role when we talk, for example, about increasing our market capacity.
In my term as head of PróGenéricos, I will work to strengthen these institutional relationships and guarantee information and even more health for Brazilians.
We aim to reach 40% of the Brazilian drug market in the next five years. Currently, our portfolio can be indicated for the treatment of more than 90% of existing diseases, including practically all chronic non-communicable diseases such as diabetes, hypertension, and hypercholesterolemia. In 24 years, generics have saved Brazilian patients more than 260 billion reais by opting to buy products in this category.
For this to happen, of course, we need integration with the axes of public power, with media and even greater engagement on social networks, with posts and campaigns that help inform the population more and more about the benefits of generics.
Another priority point for us is advocating in favor of the Patent Law. It guarantees the security and predictability of the business model that the generic drug industry needs to continue succeeding in everything that the Generics Law has achieved and allows it to go further. Respect for the Patent Law is the benchmark the entire pharmaceutical industry in the country needs to have.
EF: What opportunities do you see for generics and biosimilars when it comes to strengthening the industry of emerging markets?
TM: Generics and biosimilars are of the utmost importance to the drug industry in Brazil. 18 of the 20 largest industry players market generic drugs, which represent an important part of their sales in terms of volume and turnover. Generics help strengthen the sector as a whole, enabling it to progress.
However, this does not just translate into revenue, job creation, tax collection, etc., but opens the possibility of investment in research and development. The industry can make new generic and biosimilar drugs available, and develop new products locally. It is a virtuous cycle, and we cannot lose sight of the positive impact on the country.
EF: How is PróGenéricos engaging in partnerships and dialogues to shape sustainable policies for the Health Sector in Brazil?
TM: PróGenéricos ensures that assertive information and the mapping of impacts of decisions reaches the decision-makers, keeping bridges with the Public Authorities. We have to maintain open communication lines with Congress, the Judiciary, and the Executive if we want to build sustainable policies for the country's health sector.
For example, a misunderstanding of a "data protection" policy can lead to the late entry of generic and biosimilar drugs into Brazil simply because of a lack of knowledge of the practice and the distinction between data protection and data exclusivity. Likewise, the Judiciary needs to be aware of these products’ quality, safety, and efficacy and their importance for the treatment of millions of Brazilians. Therefore, the magistrate needs to be aware that an extension of a patent application can prolong the worsening of a disease.
Building sustainable policies involves understanding that information is the key to successful dialogue. We cannot progress on certain issues, if we do not keep all stakeholders on the same page.
EF: How is digital transformation advancing in Brazil and improving the pharmaceutical industry?
The pandemic has accelerated digital transformation worldwide in all sectors, impacting business and people management, the production process, logistics, and the relationship between the industry and its most strategic stakeholders, such as prescribers, distributors, retailers, and regulatory agents. Processes have become more agile, and the efficiency gains are undeniable.
The adoption of the Digital Package Leaflet to replace the current paper is a good example of technological innovation in Brazil. It should benefit industry, doctors, patients, and even the environment. ANVISA is currently dealing with this issue.
We are still unaware of the full potential of digitalization, considering, for example, the use of "big data" for analyzing and processing information. This type of technology provides information on consumption and is an important tool for research and development, the discovery of new medicines or combinations of already known molecules, etc.
Technological transformation will change the way we deal with health.
EF: What future do you envision for the generics market in Brazil?
TM: Generics are today the main instrument for access to medicines in the country and remain the fastest-growing segment in the Brazilian pharmaceutical industry. Not only is this a business model that has worked, but it is also a highly successful public access policy.
Since 1999, generics have grown uninterruptedly. Therefore, the future includes more and more generics. And we are going to work for it!
We are talking about a segment that continues to contribute to the modernization and expansion of the businesses of several companies that have expanded their operations, making their presence felt in innovative and more complex segments, such as biosimilars.
On this path, PróGenéricos - together with its 15 members - will continue to seek links with various sectors of society and with public and private institutions, promoting and corroborating the public debate on issues relevant to the health sector and the development of the pharmaceutical industry in the country.
EF: What is a key factor to achieve a sustainable Life Sciences market in Brazil?
TM: The sustainability of the health market in Brazil requires primary health care focused on the prevention and monitoring of patients with chronic diseases. Generics are fundamental to this access to medicines. Biosimilars reduce the costs of complex treatments, boosting the healthcare industry without compromising quality.
