The draft of Public Consultation No. 1/2025, issued by Brazil’s Drug Market Regulation Chamber (CMED), proposes a structural revision of the country’s drug pricing rules. One of the most significant changes is the expansion of the reference country basket used for international price benchmarking.
Although the proposal is still under public consultation, its level of detail and technical foundation suggest a clear direction: pricing will no longer be defined solely by product characteristics or local conditions — it will increasingly reflect the company’s global positioning.
More countries, more attention to global strategy
The draft rule establishes that the ex-factory price (PF) will be based on the prices practiced in at least five of the following countries: Germany, Norway, Japan, Mexico, Australia, Canada, Spain, United States, South Africa, France, Greece, Italy, Portugal, and the United Kingdom — in addition to the country of origin.
With a broader basket, the benchmarking process now incorporates a wider range of regulatory environments. Each country applies its own pricing policies, thresholds, and methodologies. This increases variability — and calls for more strategic coordination.
Positioning a product in more conservative pricing markets may reduce the ceiling applicable in Brazil. This already existed to some extent, but the logic is now more clearly defined. The key point is not risk, but the opportunity to use public data to make better-informed, globally aligned decisions.
Instead of navigating in the dark, companies now have a map — as long as they know where to look and how to read it.
Generics and the ripple effect
The proposed rule maintains the 65% cap on the reference price for generics. However, if the reference product is already affected by a lower international price, the generic enters the market with a compressed margin from the outset.
For example, if the PF for a reference product is set at R$100, the generic will be capped at R$65 — regardless of local production costs or clinical value. A pricing decision made in one country directly shapes the commercial viability in Brazil.
What can be done now
Even during the consultation phase, the sector can begin preparing for potential impacts. The CMED draft is extensive and technical, covering a wide range of scenarios — from innovative drugs to changes in market authorization holders.
Some proactive steps include:
- Mapping ex-factory prices across the proposed reference countries
- Identifying products vulnerable to pricing anchors
- Understanding applicable categories under the draft regulation
- Evaluating exceptions — such as the differentiated treatment for products developed and manufactured in Brazil, which would not be subject to provisional pricing
This preparation helps companies gain clarity, anticipate risks, and respond more effectively once the regulation is finalized.
Regulatory intelligence becomes a strategic asset
The CP 1/2025 proposal highlights the importance of aligning technical, regulatory, and commercial teams around traceable, internationally comparable data.
In this context, regulatory intelligence becomes a strategic function — guiding price interpretation, scenario modeling, pricing rationales, and early engagement with CMED.
Understanding the regulation is just the starting point. The real value lies in turning its criteria into operational decisions — from launch planning to price strategy and product classification.
This article is based on the webinar held on June 9, 2025, with the participation of Dr. Daniela Marreco Cerqueira (Executive Secretary of CMED).
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