New proposal aims to expand access, lower prices, and increase predictability in the pharmaceutical market, while reinforcing the role of patent strategy in regulatory compliance.
The Drug Market Regulation Chamber (CMED), under Brazil’s National Health Surveillance Agency (Anvisa), launched Public Consultation No. 1/2025 to revise Resolution No. 2/2004, which governs the country’s drug pricing policy. After more than two decades without major structural updates, the proposed revision signals a critical shift for companies, public institutions, and society as a whole.
What’s under discussion?
The draft resolution introduces several key changes, including:
- Expansion of reference country basket: The number of countries used as benchmarks to establish pricing ceilings will increase from 6 to 8, now including markets like Mexico, Colombia, and Germany. The goal is to broaden pricing comparisons and encourage more competitive pricing.
- Clearer rules and defined timelines: The proposal sets a 60-day deadline for submitting price information after regulatory approval, alongside standardized timelines for review. This brings much-needed predictability and prevents products from being registered without a concrete commercialization plan.
- Patent status documentation: Companies will be required to submit detailed proof of the patent status of each product, including active applications, extensions, and specific types of protection such as use or formulation patents. General statements will no longer suffice.
Impacts on the pharmaceutical sector
The proposed model addresses longstanding market distortions, such as the registration of products never brought to market, price anchoring to unrepresentative international values, and lack of clarity around exclusivity rights. With stricter rules and defined timelines, companies can better align their regulatory, commercial, and legal strategies.
In terms of intellectual property, this new context calls for greater focus on freedom to operate (FTO) assessments, monitoring of competitive patents, and strategic launch planning based on expiry timelines, especially for complex products like biologics and biosimilars.
Public comments open until July 5
Public Consultation No. 1/2025 will remain open for feedback until July 5, 2025. Industry professionals, companies, and institutions can access the full draft and comment form on the Anvisa website.
Why a specialized technical approach matter
The new requirements for patent documentation and compliance timelines underscore the value of a structured technical approach. Mapping IP risks and opportunities with precision is essential not only to avoid setbacks but also to ensure regulatory alignment and commercial readiness.
Specialized support can be key to navigating this landscape. Teams with experience in FTO analysis, international patent searches, and regulatory advisory services help companies bridge business goals and legal requirements with greater confidence and agility. At ClarkeModet, we’ve been closely monitoring these developments and are ready to support pharmaceutical companies operating, or planning to operate, in the Brazilian market.
