Brazil’s Ministry of Economy considers proposals for resolution on drug pricing criteria

​On September 26, 2021, the public consultation period for a proposed resolution establishing new pharmaceutical drug pricing criteria came to an end. Launched by the Brazilian Ministry of Economy’s Department of Competition (SEAE) in July 2021, the consultation received a total of 29 contributions from the public.

Currently awaiting the SEAE’s analysis, the contributions address claims related to:

• A need for a more comprehensive review of pricing in order to consider the possibility of reducing the prices currently listed in the Market Regulation Chamber for Drugs’ (CMED) table;
• A need to create boundaries for framing so-called ‘omissive cases’ (cases that fall outside the provisions of established legislation);
• The importance of making the Regulatory Impact Analysis (AIR) publicly available to reveal the motivations for launching the consultation, as well as the potential impacts that the changes may have on the sector; and
• A request to suspend the public consultation period itself. This was mainly justified by the supposedly short deadline for submitting contributions, the importance of the subject for the pharmaceutical sector, and a need for more in-depth debates on the proposed changes – including within society.

Currently, drug pricing in Brazil is primarily regulated by a 2003 law that defines regulatory standards for the pharmaceutical sector, which also led to the creation of CMED. This law is supported by a CMED resolution from 2004, which establishes criteria for pricing new products and new presentations, along with several CMED notices, including No. 09/2016, which provides for pricing criteria for existing biological drugs, and No. 10/2016, which establishes deadlines for analyzing appeals, reconsiderations, released drugs and price information documents involving omissive cases.

Bridging the divide between regulation and technology

The SEAE shares the pharmaceutical sector’s understanding that technological advances have sparked a need to discuss new legislation on drug pricing. Indeed, the inadequacy of current regulations concerning evolving products and technologies has already led to a significant number of price proposals presented by companies being rejected. In practice, this can make placing the product on the market virtually prohibitive for companies, creating harmful effects and barriers to accessing new technologies in Brazil.

Among the proposed changes to the Public Consultation’s text, we highlight the following:

• The applicability of the resolution to all synthetic, semi-synthetic, biological, radiopharmaceutical and advanced therapy drugs is expressly mentioned;
• Improvements to the pricing methodology for certain products, such as existing biological drugs;  new presentations for drugs with active ingredients already available on the Brazilian market that provide additional clinical benefits;  drugs with the same active ingredient, concentration and pharmaceutical form that arise from the transfer of ownership; and new products, which include advanced therapies and, consequently, gene therapies;
• The analysis and pricing procedure within CMED’s Executive Secretariat is outlined in greater detail; and
• Appeal deadlines for claimants have been extended in cases of rejection.

Considering the sector has been regularly calling for modernized regulations for some time, the SEAE’s move to propose a new resolution on drug pricing should be seen as commendable. However, there remains a need to further improve and develop the proposed text to ensure greater legal security and the industry’s sustainability, which would thus expand Brazilian patients’ access to new technologies.

To date, the SEAE has been open to suggestions. It is expected that the contributions received during the public consultation period will assist in reforming the resolution.

To learn more about regulations in the health sector, please contact Mattos Filho’s Life Sciences and Healthcare practice area.

*With the participation of Lucas Barreto.