Summary of Poder Entrevista: Reginaldo Arcuri, presidente do grupo FarmaBrasil

00:00:00 - 00:35:00

In this episode of the Poder Entrevista YouTube series, Guilherme Valberg interviews Reginaldo Arcuri, the president of FarmaBrasil, the representative body for Brazil's Pharmaceutical industries. Arcuri, a former Secretary of Development in the Ministry of Development, Industry and Foreign Trade, highlights the critical role of the industry in Brazil's industrialization. With over 210 million inhabitants and a universal healthcare system, the country is unable to meet its healthcare needs solely through imports. Reginaldo emphasizes the importance of the sector's focus on innovation and its significant contribution to the Brazilian economy, generating high-quality jobs, value-added, and fostering further development. The discussion covers various aspects, from vaccine production to patent regulations and the balance between innovation and copying. Arcuri emphasizes the need for localized production, efficient regulations, and international collaborations to ensure access to advanced medicines for the Brazilian population.

• 00:00:00 In this section of the video, Guilherme Valberg interviews Reginaldo Arcuri, the president of FarmaBrasil, an entity representing 12 pharmaceutical industries in Brazil. Arcuri, 68-year-old and a former secretary of development in the Ministry of Development, Industry and Foreign Trade, and president of the Brazilian Industrial Development Agency, currently integrates the National Development Agency of Industrial. Arcuri expresses that the pharmaceutical industry plays a significant role in Brazil's industrialization, since the country, with over 210 million inhabitants and a universal and free healthcare system, cannot rely on imports to meet the healthcare needs and access to high-quality healthcare for its population. Additionally, the pharmaceutical industry's focus on innovation contributes greatly to Brazil's transformation. Despite a decline in the industry's participation in the country's Gross Domestic Product (PIB), the industry generates high-quality jobs, value-added, and fosters further development. Some examples of competitive sectors in Brazil include agriculture, but the country needs new sectors similar to pharmaceuticals that can contribute to industrialization. Currently, over 170,000 direct jobs exist in the pharmaceutical sector, with high-qualification requirements. Various multinational and national companies play crucial roles in the industry, such as Bayer, investing heavily in innovation to provide quality medicines at competitive prices for Brazilians.
• 00:05:00 In this section of the "Poder Entrevista" YouTube video featuring Reginaldo Arcuri, president of the Brazilian pharmaceutical industry group FarmaBrasil, Arcuri discusses the importance and strategic role of the pharmaceutical sector in Brazil. He highlights that the industry requires significant investment and dedication, with a focus on research and development (R&D) smattering a distinctive and essential flavor to Brazilians amidst other important areas of the industry. Arcuri reveals that Brazilian pharmaceutical companies invest between 6% and 14% of their liquid revenue in R&D, significantly higher than the manufacturing industry's average in Brazil, which hovers around 2%. Notably, he mentions that international companies, with well-established headquarters and historical legacies, have traditionally led research and development efforts in pharmaceuticals worldwide. However, Brazilian domestic companies are increasingly building an innovation ecosystem in their homeland and collaborating with international corporations to pave the way for strategic growth in the sector. Moreover, Brazil's strong pharmaceutical industry was pivotal during the pandemic, contributing significantly to the production of medical equipment and vital medicines such as monoclonal antibodies – a key biological therapy.
• 00:10:00 In this section of the "Poder Entrevista" with Reginaldo Arcuri, President of the FarmaBrasil group, they discuss the production of a new vaccine from the multinational company PRHeris Hoster. Arcuri explains that this vaccine is produced using genetically engineered living cells and the process is sophisticated, similar to making a phone chip. The cells are first engineered to secrete a specific protein needed to combat a particular disease. The resulting protein is then extracted from the cell and undergoes a complex filtration process to obtain the final product, which in this case is the IFA antigen. This process is repeated in larger reactors to mass-produce the vaccine. Cloning of the master cells is also required to replicate the process. The Brazilian pharmaceutical industry is focusing on developing areas such as monoclonal antibodies and producing more effective antibiotics, utilizing Brazil's biodiversity to create new drugs. The interview emphasizes the need to ensure the population has access to these advanced technologies.
• 00:15:00 In this section of the interview, Reginaldo Arcuri, president of the FarmaBrasil group, discusses the importance of maintaining the ability to produce a diverse portfolio of medicines for Brazilians, whether through public means or private licitations. He emphasizes that the majority of suppliers are Brazilian companies, but foreign companies are also essential, especially for medicines still under patent or not yet produced in Brazil. Arcuri highlights the challenges during the pandemic when some countries suspended the supply of vaccines and essential medicines, forcing others to wait. The Brazilian government responded by developing vaccines with Chinese partners and using a technological procurement mechanism to complete the production of the AstraZeneca vaccine, ensuring access for Brazilians. He concludes by stating that the only way to ensure public health security in a country is by having a local industry capable of maintaining the market and producing essential medicines when needed.
• 00:20:00 In this section of the Poder Entrevista interview with Reginaldo Arcuri, president of FarmaBrasil, the topic of innovation versus copying in the Brazilian pharmaceutical industry is discussed. Arcuri explains that having the decision center of the company in Brazil is important for efficiency and quickness, despite criticism from the International Pharmaceutical Industry regarding a lack of innovation. He argues that copying is a natural part of commerce and gives historical examples, from ancient civilizations to the Industrial Revolution, where advancements were made through the spreading of knowledge. Arcuri also emphasizes the significance of patents, which provide a limited-time privilege for inventors but encourage innovation through competition and reduced prices once the patent expires. He concludes that learning to copy is a crucial step in mastering a particular technological stage and paving the way for new innovations.
• 00:25:00 In this section of the "Poder Entrevista" YouTube video, Reginaldo Arcuri, the president of FarmaBrasil, discusses New Molecular Entities (NMEs) and the production of generic medicines in Brazil, specifically focusing on biossimilars and the adjustments being made to the Brazilian National Industrial Property Institute (INPI) to accelerate patent registration. Currently, patents can take 10 to 15 years to be registered, but Alkmin, the Vice-President and Minister of Industry and Trade, aims to reduce this period to approximately 2 years by granting the INPI greater autonomy. The INPI's outdated infrastructure and prolonged analysis process are being addressed with internal reforms, and a proposed bill called "Marcos Pereira Law" supports this effort by offering financial and administrative autonomy to the INPI. This measure is crucial for the pharmaceutical industry, as it allows for regulatory import taxes on medicines and equipment, ensuring fair competition and innovation within the sector. The INPI's current patent extension system, which can extend patents beyond the 20-year limit, was deemed unconstitutional in 2021, resulting in confusion regarding patent protections. The Brazilian government is currently negotiating the return of import taxes on these items to maintain a balanced regulatory environment for the pharmaceutical industry.
• 00:30:00 In this section of the Poder Entrevista with Reginaldo Arcuri, president of the FarmaBrasil group, the discussion revolves around the importance of local production of medicines in Brazil and the challenges faced due to cheaper production in countries like India and China, with significant subsidies for researchers and development. Arcuri argues that these countries' abilities to produce medicines artificially cheaper makes it difficult for Brazil to compete and establish a balance for national medicine production. In contrast, the US, which is 70% of the global market for medicines and a leader in innovation, has protectionist tariffs, such as the one imposed by Trump and maintained by Biden, to safeguard their industries. In Brazil, there is a neoliberal ideology that discourages tariffs and support for the national industry, but the need is to find ways to incentivize real innovation and competitive global companies, rather than relying on subsidies. The pharmaceutical industry generates approximately 100 billion reais annually in Brazil, contributing around 3% to the PIB, and the country is in the process of developing technologically in some biotech and chemical synthesis areas. The government has shown signs of investment in this process, but the Brazilian industry seeks modern regulation focused on innovation, with coordination among various government departments, such as the Finance Ministry, Receita Federal, Ministério da Saúde, TCU, Agu CGU, and Anvisa.
• 00:35:00 In this section of the "Poder Entrevista" YouTube video, Reginaldo Arcuri, the president of FarmaBrasil, discusses the central mission of his organization, which is to ensure the safety, quality, and efficacy of medications and other related products for the Brazilian population. He emphasizes the importance of innovation and Agility in regulation, as long approval times are necessary for effective regulation but should not be excessively long due to issues of staffing or technology. Arcuri compares the approval processes and procedures of regulatory agencies such as the FDA, EMA, Health Canada, and Swiss Medical to those of INPI in Brazil. The interview was recorded at the Poder 360 studio in Brasilia on November 8, 2023. To stay informed, viewers are encouraged to subscribe to the Poder 360 channel, turn on notifications, and not miss any relevant information.