BRAZIL Trends and Developments Contributed by: Marianne Albers, Thais Fernandes and Mariana Vianna, Felsberg Advogados
America. As a result, companies may turn their focus to Brazil as a key region to expand their operations and develop their industry in a more favourable environment. In addition to the pharmaceutical sector, the die- tary supplements sector also appears promis- ing, showing considerable growth since 2022 in merger and acquisition transactions. The expec- tation is that this market will generate more than BRL10 billion annually by 2028. Another sector that is constantly expanding is the cosmetics and personal care industry. The Brazilian market is the fourth largest in the world and is continuously growing, with projections indicating that revenue will exceed USD44 bil- lion by 2029. Data shows that the growth rate for this market is over 7%. New policies currently under discussion in Con- gress and at federal regulatory agencies, such as the National Health Surveillance Agency (ANVI- SA) and the National Agency for Supplementary Health (ANS), are likely to play a crucial role in shaping the future of the industry. These regula- tory changes, alongside continued investment in innovation and healthcare infrastructure, will provide new opportunities for both domestic and foreign companies, further fuelling the expansion of the Brazilian market. Clinical Trials Brazil’s ethnic diversity, large population, high- ly trained professionals, and the credibility of its regulatory agency make it one of the most attractive countries in the world for the devel- opment of clinical trials. In response to the sec- tor’s constant demand for clearer regulations and faster procedures, the Brazilian government passed a law to regulate human clinical trials in the country.
Published in mid-2024, Federal Law 14.874 introduced significant changes regarding the responsibilities of sponsors during and after clinical trials and established defined timelines for the review and approval of research protocols by ethics committees. Although some specific regulations are still pending, the new legislation provides greater legal certainty for all parties involved. This is expected to foster increased investment from both national and international companies interested in developing their activi- ties in Brazil. Partnerships Between Public and Private Laboratories: PDPs and PDIL Brazil is one of the few countries in the world that guarantees free access to the National Health System (SUS) for its entire population, covering everything from medical consultations and sur- gical treatments to the provision of expensive, continuous medicines. Due to this high demand for products such as surgical instruments and medications, Brazil operates public laboratories that manufacture these items to reduce govern- ment costs. This public policy requires public laboratories to enter into partnerships with private companies for: (i) the transfer of technology (PDP – Partner- ship for Productive Development), enabling the public sector to manufacture products and make them available to SUS, or (ii) the development of innovative solutions for the public health sec- tor (PDIL – Local Development and Innovation Program). These partnerships are expected to grow signifi- cantly in the coming years, as the federal gov- ernment aims for 70% of SUS’s product demand to be met through local production by 2033. To achieve this goal, the government plans to invest more than BRL8 billion by 2027. Notably, the
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