CMED opens call for contributions on draft resolution for pharmaceutical pricing rules
On May 5, 2025, Public Consultation 1,330/2025 of the Brazilian Drug Market Regulation Chamber (CMED) was published in the Federal Register, opening a 60-day period for submitting comments on the text of the proposed revision of CMED Resolution 02/2004, which deals with the criteria for defining prices of new products and new presentations of medicines.
The deadline for submitting contributions ends on July 10, 2025, and they can be sent by filling out a specific electronic form available at this link. The text of the proposed new Resolution can be accessed at this link. Below are the key changes.
New categories of medicines:
The proposal for the new drug pricing regulation has a new categorization for new products and new presentations, now expressly including:
- Medicines with incremental innovation,
- Non-new biological products and biosimilars;
- Medicines resulting from transfer of ownership.
Category 1 remains applicable to new products with a molecule that is the subject of a patent in the country and that brings therapeutic gain compared to the existing therapeutic alternative in the country.
Thus, for Category 1, the only proposed change regarding the requirement for patented molecules is to clarify that molecules whose patent applications have been rejected by the Brazilian Patent and Trademark Office (BRPTO) or whose patents are no longer in force will not be considered patented. Additionally, the revised rule eliminates the current requirement to demonstrate a significant reduction in the total cost of treatment for this category.
The public consultation proposal adds another new category: medicines with incremental innovation, as Category 3. The draft defines a medicine with incremental innovation as one that demonstrates innovative activity compared to an originator medicine already registered in the country, consisting of a new association, new monodrug, new route of administration, new concentration, new pharmaceutical form, new packaging, or other incremental innovation, excluding merely aesthetic or commercial changes.
The draft transformed into Category 4 the new presentations of medicines already marketed by the same company (currently listed as Category 3).
Other novelties include the creation of Categories 7 and 8, aimed respectively at non-new biological products or biosimilars and medicines resulting from transfer of ownership.
The figure of the omissive case remains in the new proposed norm, in the same way as the resolution currently in force.
Deadline for submitting the Price Information Document (DIP) and expansion of the content and required documents:
The proposal establishes that, from the publication of the approval of Anvisa’s marketing authorization, the company has 60 days to file the DIP of all registered medicines with CMED, regardless of the prioritization of the registration process, through an electronic system. Non-compliance may result in the initiation of an ex officio procedure for defining the Factory Price (PF) by CMED.
Additionally, the draft proposes that the DIP becomes more robust in terms of documents and information. Thus, the expectation is that, with the new rules, the new DIP should contain more robust clinical, pharmacoeconomic, and scientific evidence, as well as documents proving the performance of innovative activities in the country.
It is possible to use the simplified DIP modality, applicable to companies holding drug registrations that already have a PF defined by CMED and that choose to comply with simplified sanitary registration procedures.
Changes in price definition criteria and the basket of countries:
The rule that the requested PF cannot exceed the lowest PF practiced in reference countries (price basket) remains, although it has received an expansion of the countries involved:
- Germany, Norway, Japan, Mexico, Australia, Canada, Spain, United States, South Africa, France, Greece, Italy, Portugal, United Kingdom, and the country of origin of the product.
- Today the basket consists of Australia, Canada, Spain, United States, France, Greece, Italy, New Zealand, and Portugal.
It is also proposed to increase the minimum number of countries for comparison and approval of definitive PF: from three, as provided since 2004, to five countries.
Medicines developed and manufactured in Brazil are exempt from the requirement to be marketed internationally for the definition of the definitive PF.
Regarding the definition of provisional price, the draft also expands the situations in which CMED can establish a provisional price, including:
- Medicines with active marketing authorization since March 2, 2004, that still do not have a defined price (medicines whose registration holder has never submitted the DIP).
- Medicines whose DIP was not filed within 60 days after registration.
- Medicines that are not marketed in at least five countries in the reference basket.
- Drugs for which the marketing approval is subject to a post-registration requirement for additional data and evidence, in which case the company must submit to CMED’s Executive Secretariat a Technical Report with evidence of the product’s efficacy and safety whenever such data are submitted to Anvisa’s Drug General Office.
Deadlines for CMED to communicate its decisions on DIPs:
- Up to 60 days for products classified in Categories 4, 5, 6, and 8; and
- Up to 90 days for products classified in Categories 1, 2, 3, 7 or considered an omitted case.
The Life Sciences & Healthcare team at Souto Correa Advogados will monitor the developments of the CP and is available to further explore the proposed changes.