Collaboration between Anvisa and EMA strengthens the safety, accessibility and efficiency of medical treatments, highlighting the importance of regulatory harmonization and the commitment to global public health.
In an era marked by global interconnection, the convergence of health regulatory schemes between Brazil and Europe emerges as a beacon of collaboration and sharing of expertise. The similarities and joint initiatives that have shaped these regulatory contexts, which are fundamental to promote innovation and public health safety, deserve attention.
Both Brazil and Europe prioritize strict standards in the regulation of medicines and medical technologies. At the heart of these efforts are Brazil’s National Health Surveillance Agency (Anvisa) and the European Medicines Agency (EMA). These regulatory bodies collaborate extensively, exchanging vital information, clinical trial data, and regulatory best practices. In fact, it is in this context that the EMA and Anvisa have established a commitment to share non-public information involved in their regulatory acts, strengthening technical capacities in health surveillance. This collaboration streamlines the approval process and promotes harmonized regulatory oversight, significantly increasing its efficiency and effectiveness on an international scale.
A striking example of this collaboration can be seen in the evaluation and approval of treatments for rare diseases. The joint efforts between Anvisa and EMA have facilitated rapid access to innovative therapies, such as Lecanemab for Alzheimer’s, the SRP-9001 gene therapy for Duchenne muscular dystrophy, and Pegcetacoplan, an inhibitor of complement factor C3 used in the treatment of geographic atrophy. Initiatives like this highlight a shared commitment to addressing unmet medical needs quickly and comprehensively.
The interchangeability of biosimilars represents another significant area of cooperation. Discussions between regulatory authorities on both sides of the Atlantic on this front aim to establish consistent guidelines and standards, ensuring patient safety and facilitating market access for these critical therapies.
However, despite these advances, challenges persist, especially regarding the affordability and economic sustainability of innovative treatments. In Brazil, as in Europe, balancing technological progress with the sustainability of health systems is a complex issue. The National Commission for the Incorporation of Health Technologies (Conitec) plays a crucial role in the evaluation of new treatments, ensuring that they meet rigorous scientific and economic criteria before their incorporation into the public health system.
According to recent data from the Ministry of Health, in 2023, 21 new incorporations were carried out: nine drugs for rare diseases, five for infectious diseases, two for oncology, one for chronic disease, and four for other conditions. These incorporations include drugs for diabetes, tuberculosis, HIV, multiple sclerosis, cystic fibrosis, hemophilia, myeloma, in addition to the dengue vaccine. The two oncological drugs alone are expected to benefit between 5 and 8 thousand patients in the coming years.
Brazil and Europe also emphasize public engagement and transparency in their regulatory processes. Initiatives such as public consultations by Conitec and robust stakeholder engagement by the EMA ensure that regulatory decisions are informed from diverse perspectives, strengthening trust and accountability.
Illustratively, in 2023, 33 public consultations were held in Brazil, which resulted in more than 14 thousand contributions, in addition to 32 public calls for patient participation in the commission’s meetings. This year, several new public calls have already been launched, covering a wide range of treatments, such as exocrine pancreatic insufficiency, active ankylosing spondylitis, type 1 and 2 diabetes mellitus, endometriosis, prostate cancer (abiraterone, apalutamide, darolutamide and enzalutamide), asthma (dupilumab), kidney disease (aluminum hydroxide and alfacalcidol), Parkinson’s disease (rivastigmine), human brucellosis (gentamicin sulfate associated with doxycycline), among others.
As global health challenges evolve – from pandemics to chronic diseases – international collaboration on health regulation takes the spotlight. Brazil’s strategic position in global health governance, notably in the G20 and the WHO, coupled with its proactive engagement with European partners, positions it as a key player in shaping the future of health regulation. In fact, also in this scenario where Brazil assumes a leading role, the Economic-Industrial Health Complex stands out as the main axis, whose results are awaited with great expectation.
Another important milestone was reached with the publication of the new law on clinical research on human beings. This legislation aligns Brazil’s clinical trial regulations with international best practices. Previously, Brazilian regulations were perceived as not fully harmonized with global standards, which hindered international collaboration more broadly and effectively. Now, by integrating these best practices, the legislation increases Brazil’s attractiveness as a destination for international clinical trials, and can catalyze investments in local research and development. This market, currently with a large share from Europe, can be shared more quickly with Brazil due to the collaboration already established between the jurisdictions.
The alignment and collaboration between the health regulatory systems of Brazil and Europe represent an important model of international cooperation in the face of the complexities of global health challenges. By fostering mutual understanding and leveraging shared expertise, we are driving advanced public health goals and paving the way for innovations that will benefit populations around the world. The strategic partnership goes beyond regulatory harmonization, encompassing strengthening pandemic response capacity, developing new treatments for neglected diseases, and promoting sustainable and inclusive health practices globally.
Previously published by Saude Business.
Author: Bruna Rocha, partner at Campos Mello Advogados in cooperation with DLA Piper in the Life Sciences and Healthcare sector.
