INTRODUCTION: Inequitable access to oncology care between the USA and Brazil is frequently attributed to delays in regulatory approval by ANVISA OBJECTIVES: The purpose of this research was to estimate the differences in regulatory approval timelines between the FDA (USA) and ANVISA (BRA) for oncology therapies, while distinguishing between delays in manufacturer application submissions and ANVISA regulatory processes, to understand how these delays may create inequitable patient access to care METHODS:

• A basket of twenty-three oncology products approved by ANVISA after 2002 were surveyed to evaluate the differences in regulatory submission and approval dates between the USA and Brazil
• The ANVISA and FDA regulatory approval timelines were calculated by obtaining the difference between submission and approval dates of each product’s regulatory applications; comparisons between the FDA and ANVISA timelines were drawn by taking the difference in each of the regulatory bodies’ average approval time for all products
• Delays in the manufacturers’ submission for regulatory approval in Brazil were calculated by comparing the FDA and ANVISA application submission dates for each product

RESULTS:

• The analysis revealed that on average there was a difference of 8.6 months between ANVISA and the FDA’s regulatory approval process, with ANVISA averaging approximately 449 days and the FDA 186 days from submission of an application to regulatory approval
• On average, between Brazil and the USA, the products surveyed demonstrated a delay in the manufacturers’ submission for regulatory approval of 1.1 years (393 days)

CONCLUSIONS: The results of this study indicate that there are significant differences in the regulatory approval timelines between the FDA and ANVISA which raise significant concerns over access to equitable treatment for oncology patients in these two countries. Importantly, although delays in ANVISA approval are significant, the manufacturer’s submission timing has also considerably contributed to delayed patient access to new oncology therapies in Brazil.